Decree No. 109/2016/ND-CP dated July 01, 2017 of the Government prescribing the grant of practice certificates to medical practitioners and of operation licenses for medical examination and treatment establishments

DECREE

Prescribing the grant of practice certificates to medical practitioners and of operation licenses for medical examination and treatment establishments[1]

Pursuant to the June 19, 2015 Law on Organization of the Government;

Pursuant to the November 26, 2014 Law on Investment;

Pursuant to the November 23, 2009 Law on Medical Examination and Treatment;

At the proposal of the Minister of Health;

The Government promulgates the Decree prescribing the grant of practice certificates to medical practitioners and of operation licenses to medical examination and treatment establishments.

Chapter I

GENERAL PROVISIONS

Article 1.Scope of regulation

1. This Decree prescribes:

a/ Dossiers and procedures for grant and re-grant of practice certificates to medical practitioners;

b/ Conditions, dossiers and procedures for grant, re-grant and modification of operation licenses for medical examination and treatment establishments.

2. This Decree does not regulate the grant of practice certificates to medical practitioners and of operation licenses for medical examination and treatment establishments in the army.

Article 2.Subjects of application

This Decree applies to Vietnamese agencies, organizations and individuals and Vietnam-based foreign organizations and individuals (below collectively referred to as organizations and individuals) that carry out activities related to medical examination and treatment in Vietnam.

Article 3.Interpretation of terms

1. Person responsible for professional and technical operations of a medical examination and treatment establishment is the one possessing a practice certificate as prescribed in the Law on Medical Examination and Treatment, working on a full-time basis at a medical examination and treatment establishment, having an appropriate scope of professional activity and taking responsibility before law for all professional operations of the medical examination and treatment establishment.

2. Valid copy means a copy issued from the master register or a true copy certified by a competent agency or organization or a copy appended with a signature (for individuals) or with a signature and a seal (for organizations) proving that such copy has been compared with the original. Papers granted by foreign organizations shall be consularly legalized and have their Vietnamese translations certified in accordance with Vietnamese law.

3. Full-time medical practitioner means a person who registers to work consecutively 8 hours a day within the working hours registered by his/her medical examination and treatment establishment or who works during the whole working hours registered by his/her medical examination and treatment establishment which are fewer than 8 hours a day in accordance with the labor law.

4. Part-time medical practitioner means a person who registers to work at a medical examination and treatment establishment for fewer working hours than those prescribed in Clause 3 of this Article.

Chapter II

GRANT AND RE-GRANT OF PRACTICE CERTIFICATES

Section 1

DOSSIERS AND PROCEDURES FOR GRANT AND RE-GRANT OF PRACTICE CERTIFICATES

Article 4. Cases eligible for grant or re-grant of practice certificates

1. Grant of a practice certificate applies to the following cases:

a/ First-time grant of a practice certificate;

b/ Grant of a modified practice certificate in case of change in contents of a granted practice certificate. These changes include:

- Expansion of the scope of professional activity stated in the practice certificate when the practitioner requests addition of professional techniques of a specialty outside the specified scope of professional activity;

- Change in the scope of professional activity stated in the practice certificate when the practitioner requests change in professional techniques of a specialty outside the specified scope of professional activity;

- Change in full name or date of birth in the practice certificate.

2. Re-grant of a practice certificate applies to the following cases:

a/ The practice certificate is revoked under Clause 1, Article 29 of the Law on Medical Examination and Treatment;

b/ The practice certificate is lost or damaged.

Article 5.Dossier of application for a practice certificate for Vietnamese citizens

1. An application made according to Form No. 01 in Appendix I to this Decree.

2. Valid copies of qualifications relevant to the scope of professional activity for which a practice certificate is applied, specifically:

a/ A medical degree;

b/ A bachelor’s degree in medicine granted by a foreign country and recognized by the Ministry of Education and Training to be equivalent to a university’s degree together with a certificate of completion of an additional training course of a suitable period of at least 12 months organized by a lawfully established Vietnamese training institution according to regulations of the Minister of Health. Those who possess both of these documents shall be regarded as possessing a medical doctor’s degree and granted a practice certificate bearing the doctor’s title;

c/ A bachelor’s degree in chemistry or biology or university-level pharmacist’s degree together with a certificate of completion of a medical technical training course on testing for at least 3 months or a postgraduate degree in testing;

d/ A certificate of herbalist or a certificate of owner of a traditional herbal remedy or treatment method granted by the Minister of Health or the director of a provincial-level Department of Health.

If any of the above qualifications is lost, a certificate of graduation or a valid copy of the certificate substituting for the graduation diploma granted by the training institution that has issued such qualification is required.

3. A certificate of the practicing process, made according to Form No. 02 in Appendix I to this Decree or valid copies of qualifications of resident physician, level-I medical specialist or level-II medical specialist, except for herbalists and owners of family herbal remedies or treatment methods.

4. A certificate of health granted by a medical examination and treatment establishment specified in Clause 6, Article 23 and Clause 5, Article 25 of this Decree.

5. A judicial record card.

6. A resume made according to Form No. 03 in Appendix I to this Decree, bearing the certification of the head of the applicant’s employing agency, for applicants working at medical establishments by the time of application, or by the People’s Committee of the commune, ward or township where the applicant permanently resides, for applicants not working for any medical establishment by the time of application.

7. Two 4 cm x 6 cm color photos with white background taken within 6 months before the date of application.

Article 6.Dossier of application for a practice certificate for foreigners and overseas Vietnamese

1. An application made according to Form No. 04 in Appendix I to this Decree.

2. Valid copies of medical qualifications suitable for applicants specified in Article 17 of the Law on Medical Examination and Treatment.

3. A certificate of the practicing process:

a/ For practice performed in Vietnam, this certificate shall be made according to Form No. 02 in Appendix I to this Decree;

b/ For practice performed at an overseas medical examination and treatment establishment, the certificate of the practicing practice granted by a competent person of such establishment must contain the following information: full name of the intern; date of birth; address of residence; passport number (date and place of issue); qualifications; year of graduation; place of practice; duration of practice; and remarks on the intern’s professional capacity and professional ethics.

4. A valid copy of the work permit granted by a competent Vietnamese state agency in charge of labor.

5. A valid copy of any of the following documents:

a/ A certificate of proficiency in Vietnamese, for foreigners registering to use Vietnamese in medical examination and treatment;

b/ A certificate of interpretation skills of the interpreter of the language the practitioner registers to use in medical examination and treatment and a labor contract of the interpreter with the medical examination and treatment establishment where the practitioner works;

c/ For foreigners registering to use a language other than their native language in medical examination and treatment:

- A certificate of proficiency in the language that the practitioner registers to use as prescribed in Article 17 of this Decree;

- A certificate of interpretation skills of the interpreter of the language the practitioner registers to use in medical examination and treatment as prescribed in Article 18 of this Decree and a labor contract of the interpreter signed with the medical examination and treatment establishment where the practitioner works.

6. A certificate of health suitable for providing medical examination and treatment granted by a qualified medical examination and treatment establishment under regulations of the Minister of Health or a certificate of health granted by a foreign medical examination and treatment establishment, which must be granted within 12 months before the date of application for a practice certificate.

7. A judicial record card (for persons not required to possess a work permit).

8. Two 4 cm x 6 cm color photos with white background taken within 6 months before the date of application.

Article 7.Dossiers of request for modification of practice certificates

1. A dossier for expansion of the scope of professional activity stated in the practice certificate must comprise:

a/ A written request for expansion of the scope of professional activity, made according to Form No. 05 in Appendix I to this Decree;

b/ A valid copy of the granted practice certificate;

c/ Valid copies of qualifications suitable for the scope of professional activity to be modified;

d/ A certificate of practicing process specified in Clause 3, Article 5 of this Decree suitable to the qualifications.

2. A dossier for change in the scope of professional activity stated in the practice certificate must comprise:

a/ A written request for change in the scope of professional activity made according to Form No. 06 in Appendix I to this Decree;

b/ Valid copies of qualifications relevant to the scope of professional activity to be changed;

c/ The original of the granted practice certificate;

d/ A certificate of the practicing process specified in Clause 3, Article 5 of this Decree;

dd/ Two 4 cm x 6 cm color photos with white background taken within 6 months before the date of application.

3. A dossier for change in full name and/or date of birth stated in the practice certificate must comprise:

a/ A written request for change in full name and/or date of birth, made according to Form No. 07 in Appendix I to this Decree;

b/ Valid copies of documents proving the change in full name and/or date of birth of the practitioner;

c/ The original practice certificate;

d/ Two 4 cm x 6 cm color photos with white background taken within 6 months before the date of application.

Article 8.Dossiers for re-grant of practice certificates

1. A dossier for re-grant of a practice certificate which is lost or damaged or revoked under Point a or b, Clause 1, Article 29 of the Law on Medical Examination and Treatment must comprise:

a/ A written request for re-grant of a practice certificate, made according to Form No. 08 in Appendix I to this Decree;

b/ Two 4 cm x 6 cm color photos with white background taken within 6 months before the date of application.

2. A dossier for re-grant of a practice certificate which is revoked under Point c, d, dd, e or g, Clause 1, Article 29 of the Law on Medical Examination and Treatment must comprise:

a/ A written request for re-grant of a practice certificate made according to Form No. 09 in Appendix I, for Vietnamese citizens, or Form No. 10 in Appendix I, for foreigners or overseas Vietnamese, to this Decree;

b/ A certificate of continuous updating of medical knowledge under regulations of the Minister of Health;

c/ Papers specified in Clauses 2, 4, 5, 6 and 7, Article 5 of this Decree, for Vietnamese citizens; or papers specified in Clauses 2, 4, 5, 6, 7 and 8, Article 6 of this Decree, for foreigners and overseas Vietnamese.

Article 9. Submission of dossiers for grant or re-grant of practice certificates

1. The submission of a dossier for grant or re-grant of a practice certificate specified in Articles 5, 6, 7 and 8 of this Decree is as follows:

a/ For grant or re-grant of a practice certificate in the cases specified at Points a, b and c, Clause 1, Article 26 of the Law on Medical Examination and Treatment, the applicant shall send 1 set of dossier to the Ministry of Health;

b/ The applicant for grant or re-grant of a practice certificate who is working at a medical examination and treatment establishment under the management of a provincial-level Department of Health, excluding the case specified at Point a of this Clause, shall send 1 set of dossier to the provincial-level Department of Health.

2. If the practitioner possessing a practice certificate granted by the Ministry of Health or a provincial-level Department of Health changes his/her workplace at the time of application, he/she shall submit a dossier for grant or re-grant of a practice certificate as follows:

a/ If working at a medical examination and treatment establishment under the management of a provincial-level Department of Health, he/she shall send the dossier to the provincial-level Department of Health of the locality where such medical examination and treatment establishment is located;

b/ If working at a medical examination and treatment establishment under the management of the Ministry of Health, he/she shall send the dossier to the Ministry of Health.

3. If the medical practitioner is not working for any medical examination and treatment establishment by the time of application for grant or re-grant of a practice certificate, he/she shall send the dossier to the provincial-level Department of Health of the locality where he/she registers his/her permanent residence.

Article 10. Procedures for grant and re-grant and management of practice certificates

1. After receiving a dossier for grant or re-grant of a practice certificate, the Ministry of Health or the provincial-level Department of Health (below referred to as dossier-receiving agency) shall issue a dossier receipt slip made according to the form in Appendix II to this Decree. Specifically as follows:

a/ If the dossier is submitted directly at the dossier-receiving agency and valid according to regulations, the dossier-receiving agency shall immediately give a dossier receipt slip to the applicant;

b/ If the dossier is sent by post, within 2 days after receiving the dossier (according to the postmark of the receiving post office), the dossier-receiving agency shall send a dossier receipt slip to the applicant;

2. Within 20 days from the date written on the dossier receipt slip, the dossier-receiving agency shall appraise the dossier and make an appraisal record.

3. If the dossier is valid, within 10 working days after the appraisal record is made, the dossier-receiving agency shall grant or re-grant the practice certificate.

4. For invalid dossiers:

a/ Within 5 working days after the appraisal record is made, the dossier-receiving agency shall send the applicant a written notice requesting completion of the dossier. Such notice must specify the documents to be supplemented and modified;

b/ After receiving the request for completion of the dossier, the applicant shall comply with the request and send the revised dossier to the dossier-receiving agency. The dossier-receiving agency shall send a receipt slip for the revised dossier to the applicant;

c/ The dossier-receiving agency shall continue carrying out the procedures as prescribed in Clauses 2 and 3, and at Point a, Clause 4, of this Article. If the revised dossier is still invalid, the dossier-receiving agency shall continue guiding the applicant how to complete the dossier;

d/ If the applicant fails to supplement or modify the dossier within 60 days after the dossier-receiving agency makes a request for completion of the dossier, the applicant shall re-carry out the procedures for grant or re-grant of the practice certificate.

5. Management of practice certificates:

a/ Practice certificates shall be granted by the Minister of Health according to Form No. 01 in Appendix III or by directors of provincial-level Departments of Health according to Form No. 02 in Appendix III and decisions on supplementation of the scope of professional activity in the practice certificate shall be granted by the Minister of Health or directors of provincial-level Departments of Health according to Form No. 03 in Appendix III to this Decree. The codes of the practice certificates must comply with Form No. 04 in Appendix III to this Decree; and the scope of professional activity in the practice certificates shall be written under the guidance of the Minister of Health;

b/ Dossier-receiving agencies may themselves print the practice certificates according to the forms specified at Point a of this Clause, ensuring the continuity of serial numbers of the granted practice certificates and that each practitioner be granted only one practice certificate number;

c/ Provincial-level Departments of Health may use the blank practice certificates granted by the Ministry of Health through December 31, 2016.

Article 11. Advisory councils for grant or re-grant of practice certificates

1. The Minister of Health or the director of a provincial-level Department of Health shall form an advisory council for grant or re-grant of practice certificates (below referred to as advisory council) under Clause 4, Article 28 of the Law on Medical Examination and Treatment.

2. The chairperson of an advisory council shall direct the formulation of the operation regulation for the council and submit it to the Minister of Health or the director of the provincial-level Department of Health for approval, and organize the implementation thereof.

Section 2

REGISTRATION OF MEDICAL PRACTICE

Article 12. Principles of registration of medical practice

1. A medical practitioner may work as person responsible for professional and technical operations of only one medical examination and treatment establishment.

2. A medical practitioner shall register to work as a person taking charge of only one department of one medical examination and treatment establishment, and may neither take charge of two or more departments of the same medical examination and treatment establishment nor concurrently take charge of departments of multiple medical examination and treatment establishments.

3. A medical practitioner being the person responsible for professional and technical operations of a medical examination and treatment establishment may also take charge of a department of such establishment in accordance with the scope of professional activity stated in the granted practice certificate.

4. A medical practitioner working at a medical examination and treatment establishment may register to work as a person responsible for professional and technical operations of a medical examination and treatment establishment which operates overtime.

5. A medical practitioner working at a state-owned medical examination and treatment establishment may not register to be the head of a private hospital or a medical examination and treatment establishment established and operating in accordance with the Law on Enterprises or Law on Cooperatives unless he/she is appointed by a competent state agency to participate in the management and/or direction of a state-owned medical examination and treatment establishment.

6. Any medical practitioner having registered to work as a person responsible for professional and technical operations of a medical examination and treatment establishment may register to work overtime at another medical examination and treatment establishment.

7. Any medical practitioner may register to work at one or several medical examination and treatment establishments, provided that he/she does not register to work in the same period of time at multiple medical examination and treatment establishments and the total amount of overtime work does not exceed 200 hours as prescribed in the Labor Code. The medical practitioner must ensure the reasonability of travel between the registered places of practice.

8. If a medical practitioner having registered to work at a medical examination and treatment establishment carries out medical examination and treatment activities in an alternate mode, humanitarian medical examination and treatment or performs technical operations under a contract between medical examination and treatment establishments, he/she is not required to register to practice at such establishments.

Article 13.Registration of medical practice

1. The registration of practice shall be made by the person responsible for professional and technical operations of a medical examination and treatment establishment according to the form in Appendix IV to this Decree.

2. Contents of practice registration:

a/ Place of practice: Specify name and address of the medical examination and treatment establishment for practice;

b/ Practice period: Specify time of practice: hours in a day and days of a week when the practitioner works at the medical examination and treatment establishment which ensure the reasonability of travel between the establishments that he/she has registered as prescribed at Point a of this Clause;

c/ Title and professional position of the practitioner: The list of persons registering practice must contain their titles, i.e., person responsible for professional and technical operations, person in charge of a department or another professional position.

3. If a list of persons registering practice of a medical examination and treatment establishment includes a person who is currently practicing at another medical examination and treatment establishment, his/her registration of practice must specify the time, location and his/her professional position at such establishment.

Article 14. Procedures for registration of medical practice

1. Time of practice registration:

a/ For medical examination and treatment establishments applying for operation licenses, the registration of practice for practitioners shall be carried out at the time of application for operation licenses;

b/ For medical examination and treatment establishments having obtained operation licenses which have a change in staff, within 10 working days after the change is made, the person responsible for professional and technical operations of such establishment shall notify it to the agency competent to receive the written practice registration specified in Clause 2 of this Article.

2. Receipt of written practice registrations in case of change in practitioners:

a/ The Ministry of Health shall receive written practice registrations of medical examination and treatment establishments attached to the Ministry of Health;

b/ Provincial-level Departments of Health shall receive written practice registrations of medical examination and treatment establishments based in the areas under their management, excluding those referred to at Point a of this Clause.

Article 15. Management of practice registration information

1. Within 5 working days after granting an operation license or receiving the changed list of practitioners referred to in Clause 1, Article 14 of this Decree, a provincial-level Department of Health that receives the written practice registration referred to at Point b, Clause 2, Article 14 of this Decree according to its competence shall send the list of practitioners to the Ministry of Health.

2. Within 5 working days after grating an operation license or receiving the changed list of practitioners referred to in Clause 1, Article 14 of this Decree, the Ministry of Health that receives the written practice registration referred to at Point a, Clause 2, Article 14 of this Decree according to its competence shall send the list of practitioners to the provincial-level Department of Health of the locality where the medical examination and treatment establishment of such practice registrant is located.

3. Posting of lists of practice registrants:

a/ The Ministry of Health shall post the national list of practice registrants which fully contains the information specified in Appendix IV to this Decree on its e-portal;

b/ Provincial-level Departments of Health shall post the list of practice registrants which fully contains the information specified in Appendix IV to this Decree according to their registration-receiving competence prescribed at Point b, Clause 2, Article 14 of this Decree on their websites.

Section 3

INTERSHIP FOR GRANT OF PRACTICE CERTIFICATES

Article 16.Organization of practice

1. Acceptance of interns:

a/ An intern shall send a written request for practice, made according to Form No. 01 in  Appendix V to this Decree and valid copies of healthcare-related qualifications to the medical examination and treatment establishment where he/she wishes to register for practice;

b/ After receiving a written request for practice, if approving the request, the head of the medical examination and treatment establishment shall sign a practice contract with the intern, made according to Form No. 02 in Appendix V to this Decree.

2. Assignment of practice instructors:

The head of the medical examination and treatment establishment shall issue a decision on assignment of practice instructors, made according to Form No. 03 in Appendix V to this Decree. A practice instructor may provide instruction for no more than 5 interns at a time.

3. A practice instructor must satisfy the following conditions:

a/ Possessing a practice certificate;

b/ Having a scope of professional activity relevant to the qualifications of the intern, having obtained a training degree equivalent to or higher than that of the intern and having practiced medical examination and treatment for at least 3 consecutive years.

4. Responsibilities of a practice instructor:

a/ To guide interns in medical examination and treatment;

b/ To give remarks on the practice results and take responsibility for their remarks;

c/ To take responsibility in case the intern makes professional mistakes in the practice process that affects the patient’s health and such mistake is due to the instructor’s fault.

5. Grant of certificates of the practice process: After receiving the written remarks of the practice instructor on the intern, the head of the medical examination and treatment establishment shall issue a certificate of the practice process, made according to Form No. 02 in Appendix I to this Decree.

Section 4

CRITERIA FOR RECOGNITION OF PROFICIENCY IN VIETNAMESE OR ANOTHER LANGUAGE OR ELIGIBILITY FOR MAKING TRANSLATION IN MEDICAL EXAMINATION AND TREATMENT

Article 17.Criteria for recognition of practitioners’ proficiency in Vietnamese or another language in medical examination and treatment

1. A practitioner shall be recognized to be proficient in Vietnamese for use in medical examination and treatment if he/she has been tested and recognized by an educational institution prescribed in Article 19 of this Decree, except the cases specified in Clause 3 of this Article.

2. If a practitioner registers a non-native language or Vietnamese to be used in medical examination and treatment activities, he/she shall be tested and recognized by an educational institution prescribed in Article 19 of this Decree to be proficient in the registered language, excluding the cases specified in Clause 3 of this Article.

3. A practitioner shall be recognized to be proficient in Vietnamese or another language in medical examination and treatment without having to take a test if he/she satisfies any of the following criteria:

a/ Possessing an intermediate or higher degree in medicine granted by a lawful Vietnamese or foreign training institution with the training program conducted in Vietnamese or the language which the practitioner registers to use in medical examination and treatment;

b/ Possessing a certificate of completion of a medical training course which lasts at least 12 months and is conducted in Vietnamese or the language which the practitioner registers to use in medical examination and treatment;

c/ Possessing a university degree in Vietnamese or the language the practitioner registers to use in medical examination and treatment granted by a lawful Vietnamese or foreign training institution.

The degree and certificate referred to at Points a and b of this Clause must be those granted within 5 years before the date of dossier submission.

Article 18.Criteria for recognition of eligibility for making translation in medical examination and treatment

1. A person shall be recognized to be eligible for making translation in medical examination and treatment if he/she has been tested and recognized by an educational institution prescribed in Article 19 of this Decree, except the cases specified in Clause 2 of this Article.

2. A translator may be recognized to be eligible for making translation without having to take a test if he/she meets any of the following criteria:

a/ Possessing an intermediate or higher degree in medicine granted by a lawful Vietnamese or foreign training institution with the training program conducted in the language which the translator registers to make translation in;

b/ Possessing a certificate of completion of a medical training course which lasts at least 12 months and is conducted in the language which the translator registers to make translation in;

c/ Possessing an intermediate or higher degree in medicine or traditional medicine and a university degree in foreign language suitable for the language the translator registers to make translation in.

The degree and certificate referred to at Points a and b, Clause 2 of this Article must be those granted within 5 years before the date of dossier submission.

3. A person shall work as the translator for only one medical practitioner who is providing medical examination and treatment for a patient at a time.

Article 19. Conditions for educational institutions to test and recognize proficiency in Vietnamese or another language or eligibility for making translation in medical examination and treatment

An educational institution may test and recognize the proficiency in Vietnamese or another language or eligibility for making translation in medical examination and treatment if it fully satisfies the following conditions:

1. Being a medicine university of Vietnam.

2. Having a foreign-language faculty or subject in any of the following languages: English, French, Russian, Chinese, Japanese and Korean.

3. Having a bank of exam questions for testing and recognizing proficiency in Vietnamese or good command of another language or eligibility for making translation in medical examination and treatment.

Article 20. Dossiers and procedures for grant of certificates of educational 
institutions eligible for testing and recognizing proficiency in Vietnamese or another language or eligibility for making translation in medical examination and treatment

1. A dossier must comprise:

a/ Valid copies of documents proving the establishment and operation of the educational institution;

b/ Documents proving that the educational institution has a foreign-language faculty or subject specified in Clause 2, Article 19 of this Decree and a list of lecturers working on a full-time basis for the faculty or the subject;

c/ A bank of exam questions for testing and recognizing proficiency in Vietnamese or good command of another language or eligibility for translation in medical examination and treatment of at least one of the following languages: English, French, Russian, Chinese, Japanese and Korean.

2. If an educational institution which has a certificate of eligibility for testing and recognizing proficiency in Vietnamese or another language or eligibility for making translation in medical examination and treatment applies for addition of a language for testing and recognition, the dossier must comply with Points b and c of this Clause.

3. Procedures:

a/ An educational institution shall send 1 set of dossier of application for a certificate of eligibility for testing and recognizing proficiency in Vietnamese or another language or eligibility for making translation in medical examination and treatment (below referred to as language test) as prescribed in Clause 1 of this Article to the Ministry of Health;

b/ When receiving the dossier, the Ministry of Health shall give the educational institution a dossier receipt slip made according to Form No. 01 in Appendix VI to this Decree;

c/ Within 15 days after receiving a valid dossier, the Ministry of Health shall grant a certificate of eligibility for testing language to be used in medical examination and treatment to the educational institution, made according to Form No. 02 in Appendix VI to this Decree. If rejecting the dossier, the Ministry shall issue a written reply clearly stating the reason;

d/ If the dossier is invalid, within 5 working days from the date written on the dossier receipt slip, the dossier-receiving agency shall send to the educational institution a written notice stating the contents to be modified and supplemented;

dd/ Within 15 days after receiving the modified and supplemented dossier, the dossier-receiving agency shall grant the educational institution a certificate of eligibility for testing language, made according to Form No. 02 in Appendix VI to this Decree; if rejecting the dossier, the dossier-receiving agency shall issue a written reply clearly stating the reason;

e/ Within 10 days after granting a certificate of eligibility for testing language to an educational institution, the Ministry of Health shall post the name of the educational institution on its e-portal.

Article 21. Dossiers and procedures for requesting testing and recognition of proficiency in Vietnamese or another language or eligibility for making translation in medical examination and treatment

1. A dossier of request for testing and recognition of proficiency in a language in medical examination and treatment must comprise:

a/ A written request made according to Form No. 01 in Appendix VII to this Decree;

b/ A valid copy of the unexpired people’s identity card or passport;

c/ Two 4 cm x 6 color photos with white background taken within 6 months before the date of dossier submission.

2. A dossier of request for recognition of proficiency in Vietnamese or another language or eligibility for making translation in medical examination and treatment must comprise:

a/ A written request made according to Form No. 02 in Appendix VII to this Decree;

b/ The documents specified at Points b and c, Clause 1 of this Article;

c/ Valid copies of the degree and certificate specified in Clause 3, Article 17 of this Decree, in case of requesting recognition of proficiency in Vietnamese or another language in medical examination and treatment, or of the degree and certificate specified in Clause 2, Article 18 of this Decree, in case of requesting recognition of eligibility for making translation in medical examination and treatment.

3. Procedures for testing and recognition:

a/ The requester shall send 1 set of dossier prescribed in Clause 1 of this Article to an educational institution prescribed in Article 19 of this Decree;

b/ Within 30 days after receiving a valid dossier, the educational institution shall hold a test and grant a certificate made according to Form No. 03 in Appendix VII to this Decree to a person specified in Clause 1 or 2, Article 17, or Clause 1, Article 18. Test results shall be publicly posted.

4. Recognition procedures:

a/ The requester shall send 1 set of dossier prescribed in Clause 2 of this Article to an educational institution prescribed in Article 19 of this Decree;

b/ Within 10 working days after receiving a valid dossier, the educational institution shall grant a certificate to a person specified in Clause 3, Article 17, or Clause 2, Article 18, of this Decree. If refusing to grant a certificate, the educational institution shall issue a written reply clearly stating the reason.

Chapter III

CONDITIONS, DOSSIERS AND PROCEDURES FOR GRANT, RE-GRANT AND MODIFICATION OF OPERATION LICENSES FOR MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Section 1

CONDITIONS FOR GRANT OF OPERATION LICENSES TO MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Article 22.Organizational forms of medical examination and treatment establishments

A medical examination and treatment establishment shall be established in accordance with law and organized in any of the following forms:

1. Hospital, including general hospital and specialized hospital.

2. Infirmaries of the People’s Public Security.

3. Polyclinic.

4. Specialized clinic, including:

a/ General internal medicine clinic;

b/ Specialized clinic for internal medicine: cardiology, respiratory medicine, gastroenterology, pediatrics and other specialties in internal medicine;

c/ Clinic providing health counseling or clinic providing health counseling via information and telecommunications technology;

d/ General surgery clinic;

dd/ Antenatal clinic;

e/ Clinic of andrology;

g/ Clinic of odonto-stomatology;

h/ Clinic of otolaryngology;

i/ Clinic of ophthalmology;

k/ Clinic of cosmetology;

l/ Clinic of functional rehabilitation;

m/ Clinic of psychiatry;

n/ Clinic of oncology;

o/ Clinic of dermatology;

p/ Clinic of dietetics;

q/ Clinic of drug rehabilitation;

r/ Clinic of HIV/AIDS;

s/ Clinic of opioid substitution therapy as prescribed in the Government’s Decree No. 90/2016/ND-CP of July 1, 2016, on opioid substitution therapy;

t/ Other specialized clinics.

5. Traditional medicine establishment.

6. Family medicine establishments (or medical examination and treatment establishments operating on the principle of family medicine): pilot formation under regulations of the Minister of Health.

7. Laboratory.

8. Image diagnosis clinic, X-ray room.

9. Medical assessment establishment, forensic examination establishment and forensic psychiatry establishment providing medical examination and treatment shall be organized as a medical examination and treatment establishment specified in Clause 3 of this Article. Forensic psychiatry establishment providing medical examination and treatment shall be organized as a medical examination and treatment establishment specified in Clause 1 or 3, or at Point m, Clause 4, of this Article. Such establishments must satisfy the conditions prescribed for to their respective forms of organization.

10. Maternity ward.

11. Preventive examination, counseling and treatment clinic.

12. Occupational disease clinic.

13. Medical service establishment, including:

a/ Injection, dressing change, pulse counting and temperature and blood pressure measurement service establishment;

b/ Home healthcare service establishment;

c/ Establishment providing emergency and patient transportation services in Vietnam or abroad;

d/ Optical glasses service establishment;

dd/ Cosmetological service establishment;

e/ Massage service establishment;

g/ Other healthcare service establishments.

14. Commune health stations, infirmaries.

15. Medical establishments attached to agencies, units or organizations which provide medical examination and treatment shall be organized in a form specified in Clause 3, at Point a, Clause 4, or in Clause 14, of this Article and must satisfy the conditions applicable to such form of organization.

16. A health center having a function of medical examination and treatment shall be granted a license to operate like a general hospital or a polyclinic.

17. If a medical examination and treatment establishment conducts HIV test, it shall, apart from the provisions of this Decree, comply with the provisions of the Government’s Decree No. 75/2016/ND-CP of July 1, 2016, on conditions for conducting HIV test.

18. If a medical examination and treatment establishment provides vaccination, it shall, apart from the provisions of this Decree, comply with the provisions of the Government’s Decree No. 104/2016/ND-CP of July 1, 2016, on vaccination.

19. If a medical examination and treatment establishment has a laboratory for testing microorganisms and pathology specimens likely to contain microorganisms which poses a risk of transmitting infectious diseases to humans, it shall, apart from the provisions of this Decree, comply with the provisions of the Government’s Decree No. 103/2016/ND-CP of July 1, 2016, on assurance of biosafety in laboratories.

Article 23.Conditions for grant of operation licenses to hospitals

1. Scale of hospitals:

a/ A general hospital must have at least 30 patient beds;

b/ A specialized or traditional medicine hospital must have at least 20 patient beds. Particularly, a hi-tech ophthalmologic hospital must have at least 10 patient beds.

2. Facilities:

a/ Depending on the scale of the general hospital or specialized hospital, it shall be designed and built into a block building which satisfies the following conditions:

- Departments, rooms and hallways are arranged in a way to ensure professional operations after the centralized, interconnected and self-contained complex model within the hospital premises; ensure aseptic and environmental sanitation conditions prescribed by law;

- A minimum construction floor area of 50 m² per patient bed is ensured, the hospital façade is at least 10 m wide.

b/ Satisfying the conditions of radiation safety, hospital waste disposal and fire prevention and fighting as prescribed by law.

c/ Ensuring sufficient electricity and water and other conditions for patient care.

3. Medical equipment:

a/ Having sufficient medical equipment and instruments suitable to the scope of professional activity of the hospital;

b/ Having sufficient vehicles for internal and external emergency transportation. Hospitals having no vehicles for external emergency transportation must have a transportation contract signed with a medical examination and treatment establishment having an operation license and providing emergency transportation services.

4. Organization:

a/ Departments:

- There must be at least 2 of 4 departments of internal medicine, surgery, obstetrics and pediatrics, for general hospitals, or an appropriate clinical department, for specialized hospitals;

- The medical examination department must have a place for patient reception, emergency and patient stay rooms, examination rooms and minor surgery rooms (if minor surgery is performed);

- The subclinical department must have at least one division for testing and one division for image diagnosis. Particularly, an ophthalmologic hospital having no image diagnosis section must have a professional assistance contract signed with a medical examination and treatment establishment having an operation license and an image diagnosis section;

- Pharmacy department;

- Other specialized departments and divisions as suitable to the scale, functions and tasks of the hospital.

b/ There must be functional sections of general planning, organization and personnel, quality control, convalescence, finance and accounting, and other functional sections.

5. Personnel:

a/ The number of full-time practitioners in each department must account for at least 50% of the total number of practitioners in such department.

b/ The number of staff members and title structures and standards must comply with regulations of the Minister of Health.

c/ A person responsible for professional and technical operations of a hospital must satisfy the following conditions:

- Being a doctor possessing a practice certificate with a scope of professional activity suitable to at least one of medical specialties registered by the hospital;

- Having engaged in medical examination and treatment for at least 54 months. His/her assignment or appointment must be expressed in writing;

- Working on a full-time basis at the hospital.

d/ The head of a clinical department must satisfy the following conditions:

- Being a doctor possessing a practice certificate relevant to the specialty;

- Having engaged in medical examination and treatment in such specialty for at least 54 months. His/her assignment or appointment must be expressed in writing;

- Working on a full-time basis at the hospital.

dd/ For heads of subclinical (testing, microbiology and surgery) departments:

- The head of the testing department must be a doctor or a technician specialized in testing or a chemistry or biology bachelor or a pharmacist with a university or higher degree and a practice certificate for testing.

A testing technician with a university degree may read and append his/her signature on testing results. If a medical examination and treatment establishment has no doctor specialized in testing, the doctor requesting the testing shall make the diagnosis conclusion.

- The head of the department of microbiology (for hospitals having a department of microbiology) must be a doctor or a technician possessing a university or higher degree and a practice certificate in microbiology, or a bachelor’s degree in chemistry, biology or a pharmacist possessing a university or higher degree, for persons employed to perform medical tests before the effective date of this Decree and possessing a practice certificate for microbiology.

- The head of the surgery department (for hospitals having a surgery department) must be a doctor specialized in surgery or possessing a certificate of training in surgery and a practice certificate for surgery.

- Having engaged in testing, microbiology or surgery for at least 54 months or having worked as a practitioner specialized in testing or microbiology or surgery for at least 36 months, including the period of post-graduation study in such specialties, counting from the date he/she starts the  testing, microbiology or surgery job (the date his/her labor contract is signed or the date his/her recruitment decision is issued) to the date he/she is assigned or appointed to be the person responsible for professional and technical operations of the department.

- Working on a full-time basis at the hospital.

e/ For heads of image diagnosis departments or X-ray departments:

- The head of an image diagnosis department must be a doctor possessing a practice certificate in image diagnosis and having performed medical examination and treatment involving image diagnosis for at least 54 months or having practiced image diagnosis for at least 36 months, including the period of post-graduation study in such specialty, from the date he/she starts the image diagnosis job (the date his/her labor contract is signed or the date his/her recruitment decision is issued) to the date he/she is assigned or appointed to be the person responsible for professional and technical operations of the department;

- The head of an X-ray department must be an X-ray bachelor possessing a university or higher level degree and a practice certificate and having performed medical examination and treatment involving X-ray for at least 54 months or having practiced X-ray specialty for at least 36 months, including the period of post-graduation study in such specialty, from the date he/she starts his/her X-ray-related job (the date his/her labor contract is signed or the date his/her recruitment decision is issued) to the date he/she is assigned or appointed to be the person responsible for professional and technical operations of the department. An X-ray bachelor may read and describe the diagnosis images but may not make diagnosis conclusions;

- If a medical examination and treatment establishment has no doctor specialized in image diagnosis or X-ray doctor, the doctor requesting the image diagnosis shall make the diagnosis conclusion;

- Working on a full-time basis at the hospital.

g/ The head of a pharmacy department must work on a full-time basis at the hospital and must comply with the law on pharmacy;

h/ Heads of other departments who are not required to possess a practice certificate must satisfy the following conditions:

- Possessing a university degree and having worked in such specialty for at least 36 months from the date the degree is issued to the date he/she is assigned or appointed to be the department’s head. The assignment and appointment of the head of a department shall be expressed in writing;

- Working on a full-time basis at the hospital.

i/ Apart from the persons specified at Points c, d, dd, e, g and h of this Clause, any other person working at a hospital who performs medical examination and treatment must possess a practice certificate and may only perform medical examination and treatment within the assigned scope of task. The assignment shall be made in writing and must conform with the scope of professional activity written in the practice certificate;

k/ There must be a person in charge of radiation safety (if the establishment uses radiological equipment with radiation sources and radiopharmaceuticals used in healthcare and equipment used in radiological medicine).

6. Apart from the conditions specified in this Article, a hospital performing medical check-ups and issuing health certificates must satisfy the following conditions:

a/ Personnel:

- Person making check-up conclusions must be a doctor possessing a medical practice certificate and having performed medical examination and treatment for at least 54 (fifty-four) months and assigned by a competent person of the medical examination and treatment establishment to make check-up conclusions and sign health certificates and periodic health check books. The assignment must be expressed in writing.

- Apart from the above-mentioned conditions, a medical examination and treatment establishment performing medical check-ups for foreigners or overseas Vietnamese and Vietnamese guest workers under contracts or Vietnamese studying abroad (below referred to as establishments performing medical check-ups involving foreign elements) must satisfy the following conditions:

+ The persons performing clinic examination and persons making check-up conclusions must be level-I medical specialists or masters of medicine or resident physicians or persons with higher qualifications;

+ If the person performing medical check-up and person receiving medical check-up are not proficient in the same language, a translator is required. The translator must possess a certificate of eligibility for making translation in medical examination and treatment as prescribed in Article 18 of this Decree;

b/ Professional conditions:

- For establishments performing medical check-ups without foreign elements: Having sufficient clinic examination sections, including internal medicine, pediatrics, surgery, obstetrics, optics, 
otorhinolaryngology, odontostomatology and dermatology, and 
subclinical sections, including X-ray room and laboratory.

- For establishments performing medical check-ups involving foreign elements, apart from the above-mentioned conditions, the following subclinical techniques must be carried out:

+ Blood testing: blood formula, ABO blood type, Rh blood type, rate of blood sedimentation, hemoglobin rate and rate of uremia;

+ Finding of plasmodium in blood;

+ Testing for A, B, C and E hepatitis;

+ Serological test for syphilis;

+ HIV test;

+ Mantoux reaction test;

+ Pregnancy test;

+ Drug test;

+ Fecal screening for parasites;

+ Electrocardiogram measurement;

+ Electroencephalography (EEG) measurement;

+ Supersonic test;

+ Diagnostic test for leprosy.

If the establishment is not eligible for carrying out HIV tests, diagnostic tests for leprosy and EEG measurement, it must have a professional support contract signed with a medical examination and treatment establishment having an operation license and eligible for performing such techniques.

- For establishments performing medical check-ups for drivers, apart from the conditions applied to establishments performing medical check-ups without foreign elements, the following techniques must be carried out:

+ EEG measurement;

+ Visual-field measurement;

+ Testing for determination of blood alcohol concentration and breath alcohol concentration;

+ Drug tests and psychotropic substance tests.

If an establishment performing medical check-ups for drivers is not eligible for performing EEG measurement or visual-field measurement, it must have a professional support contract signed with a medical examination and treatment establishment having an operation license and eligible for performing such techniques.

c/ Equipment: Having sufficient medical equipment and instruments suitable for professional activities and the medical check-up contents.

d/ A medical examination and treatment establishment performing medical check-ups shall compile a dossier and carry out procedures for declaration of its eligibility for performing medical check-ups according to Clause 8, Article 43, and Clauses 4 and 5, Article 44, of this Decree after it is granted an operation license.

Article 24.Conditions for grant of operation licenses for infirmaries in the People’s Public Security force

1. Scale:

An infirmary must have at least 10 patient beds.

2. Facilities:

a/ Having a place for patient reception, consulting room, emergency room, patient room and laboratory with an area sufficient for the use of equipment and instruments serving medical examination and treatment;

b/ Satisfying the conditions on radiation safety, hospital waste management and fire prevention and fighting as prescribed by law;

c/ Ensuring sufficient electricity and water and other conditions for patient care.

3. Medical equipment:

Having sufficient medical equipment and instruments suitable to the registered scope of professional activity.

4. Organization: Having at least internal medicine and surgery specialties which have emergency rooms, patient rooms and subclinical units.

5. Personnel:

a/ The person responsible for professional and technical operations of an infirmary must be a doctor with a practice certificate relevant to one of the specialties registered by the infirmary and have performed medical examination and treatment in such specialty for at least 54 months;

b/ Apart from the person responsible for professional and technical operations of the infirmary, other persons working at the infirmary who perform medical examination and treatment must possess a practice certificate and may only perform medical examination and treatment within the assigned scope of task. The assignment must conform with the scope of professional activity written in the practice certificate of the concerned person.

Article 25.Conditions for grant of operation licenses for polyclinics

1. Scale of a polyclinic:

a/ A polyclinic must have at least the following:

- Two of the 4 specialties of internal medicine, surgery, obstetrics and pediatrics;

- Emergency rooms, minor surgery rooms (if any minor surgery is carried out), patient stay rooms;

- Testing and image diagnosis units.

b/ A polyclinic satisfying the conditions on healthcare service establishments prescribed in Articles 33, 34, 35, 36, 37 and 38 of this Decree may apply for expansion of its scale and scope of professional activity as appropriate.

2. Facilities:

a/ Having a fixed location separate from areas for residential activities, having sufficient light, dustproof ceiling, and walls and floor made of materials which can be cleansed easily;

b/ Having a place for patient reception, emergency and patient stay rooms, specialized examination rooms and minor surgery rooms (if any minor surgery is carried out). Rooms in a polyclinic must satisfy the following area conditions:

- An emergency room has an area of at least 12 m²;

- A patient stay room has an area of at least 15 m² with at least 2 patient beds. If the patient stay room has 3 or more patient beds, the area for each bed is at least 5 m²;

- Specialized examination rooms and the minor surgery room have an area of at least 10 m².

c/ Satisfying the conditions on radiation safety, hospital waste disposal and fire prevention and fighting as prescribed by law.

d/ Ensuring sufficient electricity and water and other conditions for patient care.

3. Medical equipment:

a/ Having sufficient medical equipment and instruments suitable to the scope of professional activity registered by the polyclinic;

b/ Having anti-shock first aid kits and sufficient specialized emergency medicines.

4. Personnel:

a/ The number of full-time doctors must account for at least 50% of the total number of doctors of the polyclinic who perform medical examination and treatment;

b/ The person responsible for professional and technical operations of a polyclinic must satisfy the following conditions:

- Being a doctor who possesses a practice certificate relevant to at least one of the specialties registered by the polyclinic;

- Having performed medical examination and treatment for at least 54 months. His/her assignment or appointment must be expressed in writing;

- Working on a full-time basis at the polyclinic.

c/ The number of staff members, the structure and the professional titles in the polyclinic must comply with regulations of the Minister of Health.

If wishing to perform medical examination and treatment, persons other than the person responsible for professional and technical operations of a polyclinic working in the polyclinic must possess a practice certificate and be assigned in accordance with the scope of professional activity stated in their practice certificates.

5. A polyclinic wishing to perform medical check-ups must satisfy the conditions specified in Clause 6, Article 23 of this Decree.

6. Family medicine establishments must comply with regulations of the Minister of Health.

Article 26.Conditions for grant of operation licenses for specialized clinics

1. Facilities:

a/ Satisfying the conditions prescribed at Point a, Clause 2, Article 25 of this Decree;

b/ Having medical examination and treatment rooms each having an area of at least 10 m² and a place for patient reception (excluding clinics providing health counseling or clinics providing health counseling via information and telecommunications technology media). Particularly, surgery or cosmetological clinics must have patient stay rooms each having an area of at least 12 m²; clinics of functional rehabilitation must have functional rehabilitation rooms each having an area of at least 10 m²; clinics of HIV/AIDS examination and treatment must have an area of at least 18 m² (excluding the waiting area) each and be divided into 2 rooms for medical examination and counseling for patents;

c/ Apart from the conditions prescribed at Points a and b of this Clause, depending on the registered scope of professional activity, a specialized clinic must satisfy the following conditions:

- If any operation is performed, including dental implant, the operation room must have an area of at least 10 m²;

- If any functional probe is performed, the probing room must have an area of at least 10 m²;

- If any gynecological examination or examination of sexually transmitted diseases is performed, the examination room must have an area of at least 10 m²;

- If the family planning techniques are performed, the room used for such techniques must have an area of at least 10 m²;

- The room for forming surgical cast must have an area of at least 10 m²;

- The room for therapeutic exercise must have an area of at least 20 m²;

- For an odonto-stomatology clinic having more than 1 dental chair, the space for each dental chair must be at least 5 m²;

- Specialized clinics using radiological equipment (including dental X-ray equipment mounted on dental chairs) must comply with the law on radiation safety;

- Clinics of HIV/AIDS examination and treatment providing antiretroviral (ARV) drugs must have a place for antiretroviral drugs storage and dispersal which satisfies the conditions set by the Minister of Health.

d/ There must be a separate sterilization area for treating medical instruments for reuse.

dd/ Satisfying the conditions on radiation safety, hospital waste disposal and fire prevention and fighting as prescribed by law; ensuring the aseptic condition in operation rooms.

e/ Ensuring sufficient electricity and water and other conditions for patient care.

2. Medical equipment:

a/ Having sufficient medical equipment and instruments suitable to the scope of professional activity registered by the establishment;

b/ Having anti-shock first aid kits and sufficient specialized emergency medicines;

c/ Clinics providing health counseling or clinics providing health counseling via information and telecommunications technology media are not required to have medical equipment and instruments specified at Points a and b of this Clause but must have sufficient information and telecommunications technology equipment suitable to the registered scope of professional activity.

3. Personnel:

a/ The person responsible for professional and technical operations of a specialized clinic must satisfy the following conditions:

- Being a doctor who possesses a practice certificate relevant to the specialties registered by the clinic.

- Having performed medical examination and treatment in such specialty for at least 54 months.

The person responsible for professional and technical operations of any of the following specialized clinics must satisfy the following conditions:

+ Clinics of functional rehabilitation: Being a doctor who possesses a practice certificate in physical therapy or functional rehabilitation;

+ Clinics of drug rehabilitation: Being a psychiatric doctor or a general practitioner who possesses a certificate of training in psychiatry or a traditional medicine practitioner who possesses a certificate of training in drug rehabilitation using traditional medicine;

+ Clinics of HIV/AIDS examination and treatment: Being a doctor of infectious disease specialty or a general practitioner who possesses a certificate of training in HIV/AIDS treatment;

+ Clinics of dietetics: Being a dieting expert or a general practitioner who possesses a certificate of training in dieting;

+ Clinics of cosmetic surgery: Being a plastic surgeon or a cosmetological doctor;

+ Clinics of andrology: Being an andrological doctor or a general practitioner who possesses a certificate of training in andrology.

b/ If wishing to perform medical examination and treatment, persons other than the person responsible for professional and technical operations of a specialized clinic working in the specialized clinic must possess a practice certificate and be assigned in accordance with the scope of professional activity specified in their practice certificates.

Article 27.Conditions for grant of operation licenses for traditional medicine clinics

1. Facilities:

a/ Satisfying the conditions prescribed at Point a, Clause 2, Article 25 of this Decree;

b/ Having an area of at least 10 m² and having a place for patient reception;

c/ Depending on the registered scope of professional activity, a traditional medicine clinic must satisfy the following conditions:

- If providing acupuncture, massage and acupressure, it must have a room or a place with beds for acupuncture, massage and acupressure and an area of at least 5 m² for each bed;

- If providing medicinal sauna, it must have a sauna chamber of at least 2 m²in area, closed and well-lit;

d/ Satisfying the conditions on radiation safety (if any radiological equipment is used), hospital waste disposal and fire prevention and fighting as prescribed by law;

dd/ Ensuring sufficient electricity and water and other conditions for patient care.

2. Medical equipment:

a/ For clinics providing medical examination, giving prescriptions and medicinal herb recipes:

- There are herb cabinets with medicinal herbs and substances contained in drawers or securely covered glass bottles or transparent-plastic pots with labels showing names of the medicinal herbs;

- There are herb scales and herb-wrapping papers (other than newspapers or paper sheets with printed or written words); medicinal herbs shall be divided according to recipes.

b/ For clinics providing acupuncture, massage and acupressure:

- There are beds for acupuncture, massage and acupressure;

- There are sufficient instruments for acupuncture, massage and acupressure;

- There are sufficient instruments for and instructions on relief of over-acupuncture.

c/ Clinics providing medicinal sauna must have a medicinal steam system, control valves, sauna instructions and an alarm system for emergencies.

3. Personnel:

a/ A person working at an establishment who wishes to perform medical examination and treatment must possess a practice certificate and be assigned in accordance with the scope of professional activity stated in his/her practice certificate;

b/ The person responsible for professional and technical operations of a traditional medicine clinic must be a doctor or a doctor assistant specialized in traditional medicine or a person possessing a certificate of herbalist granted by the Minister of Health or the director of a provincial-level Department of Health, or an owner of family remedies or treatment methods who must possess a certificate of traditional medicine practice.

- Having performed medical examination and treatment using traditional medicine for at least 54 months, for traditional medicine doctors;

- Having performed medical examination and treatment using traditional medicine for at least 48 months, for traditional medicine doctor assistants;

- Having performed medical examination and treatment using traditional medicine for at least 36 months, for herbalists or owners of family remedies or treatment methods;

- Working on a full-time basis at the traditional medicine clinic.

Article 28.Conditions for grant of operation licenses for laboratories

1. Facilities:

a/ Satisfying the conditions prescribed at Points a, dd and e, Clause 1, Article 26 of this Decree and the following conditions corresponding to the registered scope of professional activity:

- For hematology or biochemistry or medical genetics or immunity tests, the laboratory must have an area of at least 10 m²;

- For two or three of hematology, biochemistry, medical genetics and immunity tests, the laboratory must have an area of at least 15 m²;

- For all hematology, biochemistry, medical genetics and immunity tests, the laboratory must have an area of at least 20 m²;

- For pathoanatomic or cytological tests, the laboratory must have an area of at least 20 m² and be separated from the laboratories for tests of hematology, biochemistry, medical genetics and other laboratories;

- For tests of microorganisms, the laboratory must have an area of at least 20 m² and be separated from the laboratories for tests of hematology, biochemistry, medical genetics and other laboratories;

- Walls of laboratories must have waterproof surface up to the ceiling;

- Floors of laboratories must have waterproof and flat surface which can prevent water standing;

- Testing tables must be made of watertight and anti-corrosive materials and mounted with wash basins and clean-water taps;

- There must be places for taking test specimens, places for keeping test specimens and places for cleansing medical instruments;

- A laboratory conducting tests of microorganisms likely to transmit infectious diseases to humans must satisfy the conditions prescribed by the law on biosafety in laboratories;

- HIV testing laboratories must comply with the law on HIV/AIDS prevention and control.

b/ Ensuring hospital waste disposal and fire prevention and fighting in accordance with law.

c/ Ensuring sufficient electricity and water and other conditions for patient care.

2. Medical equipment:

Having sufficient testing equipment and medical instruments for the registered scope of professional activity, including at least sufficient equipment for conducting one of the six microorganism, biochemistry, hematology, immunity, pathoanatomy and cytology, and medical genetics tests.

3. Personnel:

a/ A person working at an establishment who wishes to perform medical examination and treatment must possess a practice certificate and be assigned in accordance with the scope of professional activity stated in his/her practice certificate;

b/ The person responsible for professional and technical operations of a laboratory must satisfy the following conditions:

- Being a doctor or a technician possessing a university or higher degree and a practice certificate in testing; or a person possessing a bachelor’s degree in chemistry or biology or a pharmacist possessing a university degree, for persons employed to conduct medical tests before the effective date of this Decree and possessing a certificate of practice in testing with technician’s title.

- Having worked for a suitable laboratory for at least 54 months or having worked as a testing practitioner for at least 36 months, including the period of post-graduation study in testing, from the date he/she starts his/her testing job (the date his/her labor contract is signed or the date his/her recruitment decision is issued) to the date he/she is assigned or appointed to be the person responsible for professional and technical operations of the laboratory.

- Working on a full-time basis at the laboratory.

Article 29.Conditions for grant of operation licenses for image diagnosis clinics and X-ray rooms

1. Facilities:

a/ Satisfying the conditions prescribed at Points a, Clause 2, Article 25 of this Decree and the following conditions corresponding to the registered scope of professional activity:

- Ultrasonic and endoscopic diagnosis rooms must be independent, each having an area of at least 10 m²;

- If both upper and lower gastroendoscopic techniques are conducted, they must be conducted in two separate rooms, each having an area of at least 10 m².

b/ Satisfying the conditions on radiation safety, hospital waste and hazardous waste (if any) disposal and fire prevention and fighting as prescribed by law;

c/ Ensuring sufficient electricity and water supply and other conditions for patient care.

2. Medical equipment:

a/ Having sufficient medical equipment and instruments suitable to the registered scope of professional activity;

b/ Having personal protection devices required by the law on radiation safety.

3. Personnel:

a/ A person working at an establishment who wishes to perform medical examination and treatment must possess a practice certificate and be assigned in accordance with the scope of professional activity stated in his/her practice certificate;

b/ The person responsible for professional and technical operations of an image diagnosis clinic must be a doctor who possesses a practice certificate in image diagnosis and have performed medical examination and treatment involving image diagnosis for at least 54 months and work on a full-time basis at the image diagnosis clinic;

c/ The person responsible for professional and technical operations of an X-ray room must be an image diagnosis doctor or an X-ray bachelor who possesses a university or higher degree and has worked in X-ray therapy for at least 54 months. X-ray bachelors may read and describe the diagnosis images but may not make diagnosis conclusions. They must work on a full-time basis at X-ray rooms.

Article 30.Conditions for grant of operation licenses for maternity wards

1. Facilities:

a/ Satisfying the conditions prescribed at Point a, Clause 2, Article 25 of this Decree;

b/ Functional rooms must be reasonably interconnected and convenient for emergency and medical examination and treatment;

c/ Having rooms for prenatal and gynecological check-ups and family planning techniques, each having an area of at least 10 m²; delivery rooms each having an area of at least 16 m² including an area for women who have just delivered and their newborns; rooms for lying-in women each having an area of at least 10 m². If the room for lying-in women has more than 2 beds, there must be at least 5 m²for a bed;

d/ Satisfying the conditions on radiation safety (if any radiological equipment is used), hospital waste disposal and fire prevention and fighting as prescribed by law;

dd/ Ensuring sufficient electricity and water and other conditions for patient care.

2. Medical equipment:

a/ Having sufficient medical equipment and instruments suitable to the registered scope of professional activity;

b/ Having sufficient vehicles for internal and external emergency transportation. Maternity wards having no vehicles for external emergency transportation must have a transportation contract signed with a medical examination and treatment establishment having an operation license and permitted to provide emergency transportation services;

c/ Having anti-shock first aid kits and sufficient specialized emergency medicines.

3. Organization and personnel:

a/ A person working at a maternity ward who wishes to perform medical examination and treatment must possess a practice certificate and be assigned in accordance with the scope of professional activity stated in his/her practice certificate.

b/ The person responsible for professional and technical operations of a maternity ward must satisfy the following conditions:

- Being a gynecological doctor or a midwife who graduated from a university and has a practice certificate;

- Having performed medical examination and treatment in gynecology for at least 54 months;

- Working on a full-time basis at the maternity ward.

4. A maternity ward eligible for providing pediatric care services according to Article 26 of this Decree and provides vaccination according to the law on vaccination may add such specialties to its scope of professional activity.

Article 31.Conditions for grant of operation licenses for preventive examination, counseling and treatment clinics

1. Scale:

A preventive examination, counseling and treatment clinic may have a scale equivalent to that of a polyclinic or a specialized clinic, depending on the legal basis for establishment of such clinic.

2. Facilities:

A preventive examination, counseling and treatment clinic with a scale equivalent to that of a polyclinic must have facilities satisfying the conditions prescribed in Clause 2, Article 25 of this Decree. A preventive examination, counseling and treatment clinic with a scale equivalent to that of a specialized clinic must have facilities satisfying the conditions prescribed in Clause 1, Article 26 of this Decree.

3. Medical equipment:

Satisfying the conditions on medical equipment suitable for the scale of a polyclinic specified in Clause 3, Article 25, or the scale of a specialized clinic specified in Clause 2, Article 26, of this Decree.

4. Personnel:

a/ A person working at an establishment who wishes to perform medical examination and treatment must possess a practice certificate and be assigned in accordance with the scope of professional activity stated in his/her practice certificate;

b/ The person responsible for professional and technical operations of a preventive examination, counseling and treatment clinic must be a general practitioner who possesses a practice certificate or a doctor who possesses a practice certificate relevant to the specialty and having performed medical examination and treatment for at least 54 months and working on a full-time basis at the clinic.

5. A clinic providing vaccination or treatment bio-products must comply with the law on vaccination.

Article 32.Conditions for grant of operation licenses for occupational disease clinics

1. Scale:

An occupational disease clinic may have a scale equivalent to a polyclinic or a specialized clinic, depending on the legal basis for establishment of such clinic.

2. Facilities:

a/ An occupational disease clinic with a scale equivalent to that of a polyclinic must have facilities satisfying the conditions prescribed in Clause 2, Article 25 of this Decree. An occupational disease clinic with a scale equivalent to that of a specialized clinic must have facilities satisfying the conditions prescribed in Clause 1, Article 26 of this Decree;

b/ Having at least 2 units for testing (biochemistry, toxicity and microorganism) and image diagnosis.

3. Medical equipment:

a/ An occupational disease clinic with a scale equivalent to that of a polyclinic must have medical equipment satisfying the conditions prescribed in Clause 3, Article 25 of this Decree. An occupational disease clinic with a scale equivalent to that of a specialized clinic must have medical equipment satisfying the conditions prescribed in Clause 2, Article 26 of this Decree;

b/ Satisfying the conditions on medical equipment used for testing specified in Clause 2, Article 28, and conditions on medical equipment used for image diagnosis specified in Clause 2, Article 29, of this Decree.

4. Personnel:

a/ A person working at an establishment who wishes to perform medical examination and treatment must possess a practice certificate and a certificate of training in occupational diseases and be assigned in accordance with the scope of professional activity stated in his/her practice certificate;

b/ The person responsible for professional and technical operations of an occupational disease clinic must satisfy the following conditions:

- Being a doctor specialized in occupational diseases who possesses a practice certificate or a general practitioner who possesses a practice certificate and a certificate of training in occupational diseases;

- Having performed medical examination and treatment of occupational diseases for at least 54 months;

- Working on a full-time basis in the clinic.

Article 33.Conditions for grant of operation licenses for injection, dressing change, pulse counting and temperature and blood pressure measurement service establishments

1. Facilities:

a/ Having a fixed location, being well-lit and separated from places for residential activities;

b/ A room for injection or dressing change must have an area of at least 10 m²;

c/ Having sufficient electricity and water supply and satisfy other sanitation conditions for patient care.

2. Medical equipment:

a/ Having sufficient medical equipment and instruments suitable to the registered scope of professional activity;

b/ Having anti-shock first aid kits.

3. Personnel:

a/ A person working at an establishment who wishes to perform medical examination and treatment must possess a practice certificate and be assigned in accordance with the scope of professional activity stated in his/her practice certificate;

b/ The person responsible for professional and technical operations of an injection, dressing change, pulse counting and temperature and blood pressure measurement service establishment must satisfy the following conditions:

- Possessing an intermediate or higher degree in medicine and a practice certificate;

- Having performed injection, dressing change, pulse counting and temperature and blood pressure measurement for at least 45 months;

- Working on a full-time basis at the establishment.

Article 34.Conditions for grant of operation licenses for home healthcare service establishments

An establishment providing home healthcare services including dressing change, suture removal; physical therapy, functional rehabilitation; mother and baby care; collection of blood samples for testing, result provision; care of cancer patients and other home nursing services must satisfy the following conditions:

1. Medical equipment:

Having sufficient medical equipment and instruments suitable to the registered scope of professional activity.

2. Personnel:

a/ A person working at an establishment who wishes to perform medical examination and treatment must possess a practice certificate and be assigned in accordance with the scope of professional activity stated in his/her practice certificate;

b/ The person responsible for professional and technical operations of a home healthcare service establishment must possess an immediate or higher degree in medicine and a practice certificate and have performed medical examination and treatment for at least 45 months.

- Working on a full-time basis at the establishment.

Article 35.Conditions for grant of operation licenses for emergency or patient transportation service establishments

1. Facilities:

a/ Having a fixed location, being well-lit and separated from places for residential activities;

b/ Ensuring sufficient electricity and water and other sanitary conditions for patient care.

2. Medical equipment and transportation vehicles:

a/ Having transportation vehicles with sufficient medical equipment and instruments;

b/ Having anti-shock first aid kits and sufficient first-aid medicines for keeping patients safe and ensuring hygienic conditions for them.

3. Personnel:

a/ A person working at an establishment who wishes to perform medical examination and treatment must possess a practice certificate and be assigned in accordance with the scope of professional activity stated in his/her practice certificate;

b/ The person responsible for professional and technical operations of an establishment providing emergency and patient transportation services in Vietnam and abroad must satisfy the following conditions:

- Being a doctor who possesses a practice certificate;

- Possessing a professional qualification or certificate of study in the specialty of recuperation and first aid;

- Having performed medical examination and treatment for at least 54 months.

- Working on a full-time basis at the establishment.

4. In case of registration for patient transportation abroad, an emergency service establishment must have a contract signed with an aviation service company.

Article 36.Conditions for grant of operation licenses for optical glasses service establishments

1. Facilities:

a/ Having a fixed location, being well-lit and separated from places for residential activities;

b/ Having an area of at least 15 m²;

c/ Ensuring sufficient electricity and water and other sanitary conditions for patient care.

2. Medical equipment:

a/ Having sufficient medical equipment and instruments suitable to the registered scope of professional activity.

3. Personnel:

a/ A person working at an optical glasses service establishment must possess a practice certificate of examination and treatment in ophthalmology or of refractive eye defect measurement and diagnosis and be assigned in accordance with the scope of professional activity stated in his/her practice certificate.;

b/ The person responsible for professional and technical operations of an optical glasses service establishment must satisfy the following conditions;

- Possessing an intermediate or higher degree in medicine and a practice certificate of the specialty of ophthalmology or refractive eye defect measurement and diagnosis;

- Having worked as an ophthalmologist at a medical examination and treatment establishment or performed the measurement, checking and diagnosis of refractive eye defects at an optical glasses service establishment for at least 36 months.

- Working on a full-time basis at the establishment.

Article 37.Conditions for grant of operation licenses for cosmetological service establishments

1. A cosmetological service establishment may only do tattoos or spray or embroider pictures on the skin without using anesthetics in injection form and must satisfy the following conditions:

a/ Facilities:

- Having a fixed location;

- Ensuring the sanitary conditions.

b/ Equipment:

Having sufficient equipment, instruments and materials of clear origin which are suitable for the operation scale of the establishment.

c/ Personnel:

A person doing tattoos or spraying or embroidering pictures on the skin without using anesthetics in injection form at a cosmetological service establishment must possess a certificate of training in such job granted by a lawful training or vocational training institution;

d/ Cosmetological service establishments are exempted from operation license but shall send a written notice of satisfaction of all conditions specified at Points a, b and c of this Clause to the provincial-level Department of Health of the locality where it is located at least 10 days before it begins providing the services. The notice shall be made according to the form in Appendix VIII to this Decree.

2. Cosmetological services involving the intervention of drugs, substances and equipment in human body (surgery, operation, intervention involving injection, pumping, ray emission, burning or other types of intervention) that change the color of skin, shape, weight and defects of human body (skin, nose, eyes, lips, face, breast, belly, buttock and other parts) or services of doing tattoos or spraying or embroidering pictures on the skin without using anesthetics in injection form shall be conducted only at hospitals having cosmetological departments or cosmetological clinics or at medical examination and treatment establishments with the scope of professional activity in cosmetological specialty approved by competent agencies.

Article 38.Conditions for grant of operation licenses for massage service establishments

1. Facilities:

a/ Having a fixed location, being well-lit and separated from places for residential activities;

b/ Massage rooms must satisfy the following conditions:

- Each massage room must have an emergency bell for one-way contact from the massage room to the doctor’s room or the customer reception place;

- Having the massage technical process printed in big readable letters (on A1-size paper) affixed or hung on the wall.

c/ Being furnished with a hygienic bathroom ensuring sufficient electricity and water and other sanitary conditions for customer care.

2. Equipment:

a/ Having massage beds or chairs or pads with bed spreads, pillows and bath towels ensuring hygienic conditions;

b/ Having examination beds, first aid kits, desks and medical instruments (stethoscope, blood pressure meter, thermometer, syringes and needles) at the doctor’s room;

c/ Having sufficient common first-aid medicines.

3. Personnel:

a/ The person responsible for professional and technical operations of a massage service establishment must be a doctor or a doctor assistant or technician specialized in functional rehabilitation, physical therapy or traditional medicine or possessing a certificate of training in any of such specialties. If giving prescriptions, such person must be a doctor specialized in functional rehabilitation, physical therapy or traditional medicine;

b/ A person working at the establishment who wishes to perform massage techniques must possess a certificate of training in massage granted by a lawful training institution.

Massage technicians must wear tidy, clean and beautiful uniforms with badges showing the name of the establishment, his/her full name and 3 cm x 4 cm photo.

4. Massage service establishments are exempted from operation license but shall send a written notice of satisfaction of all conditions specified in Clauses 1, 2 and 3 of this Article to the provincial-level Department of Health of the locality where it is located within 10 days before it begins providing the services. The notice shall be made according to the form in Appendix IX to this Decree.

Article 39.Conditions for grant of operation licenses for commune-level health stations and infirmaries

1. Facilities:

a/ Ensuring the design required by the Minister of Health;

b/ Satisfying the conditions on radiation safety, hospital waste disposal and fire prevention and fighting as prescribed by law;

c/ Ensuring sufficient electricity and water and other conditions for patient care.

2. Medical equipment:

a/ Having sufficient medical equipment and instruments suitable to the registered scope of professional activity;

b/ Having anti-shock first aid kits.

3. Personnel:

a/ The person responsible for professional and technical operations must satisfy the following conditions:

- Being a doctor or a doctor assistant who possesses a practice certificate;

- Having performed medical examination and treatment for at least 54 months, for doctors, or 45 months, for doctor assistants.

b/ The number of practitioners working for a commune-level health station must satisfy the payroll norm prescribed by law for state-owned medical establishments.

c/ Village health workers shall provide primary health care according to the assignment and professional direction by heads of commune health stations.

4. Commune health stations that perform medical examination and treatment on the principle of family medicine must comply with the Minister of Health’s regulations of on pilot implementation.

Article 40.Scope of professional activity of medical examination and treatment establishments

Depending on the organization of medical examination and treatment establishments and the conditions for grant of operation licenses to these establishments prescribed in this Decree, the Minister of Health shall prescribe the scope of professional activity for each form of organization of medical examination and treatment establishment, except cosmetological service establishments and massage service establishments.

Article 41.Signboards of medical examination and treatment establishments

A medical examination and treatment establishment having an operation license must have signboards conformable with regulations on signboards which must not contain red-cross symbols and must contain the following basic details:

1. Full name of the establishment, serial number of the operation license.

2. Address of the establishment as written in the operation license; phone number.

3. Daily working hours.

Section 2

COMPETENCE, DOSSIERS AND PROCEDURES FOR GRANT, RE-GRANT AND MODIFICATION OF OPERATION LICENSES FOR MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Article 42. Competence to grant, re-grant and modify operation licenses for medical examination and treatment establishments

1. The Minister of Health has the competence to grant, re-grant or modify operation licenses for medical examination and treatment establishments in accordance with Clause 1, Article 45 of the Law on Medical Examination and Treatment.

2. Directors of provincial-level Departments of Health have the competence to grant, re-grant or modify operation licenses for medical examination and treatment establishments specified in Clause 2, Article 45 of the Law on Medical Examination and Treatment.

Article 43. Dossiers for grant, re-grant and modification of operation licenses and replacement of persons responsible for professional and technical operations of medical examination and treatment establishments, announcement of eligibility for performing medical check-ups

1. A dossier of application for an operation license for a medical examination and treatment establishment must comply with Clause 1, Article 46 of the Law on Medical Examination and Treatment, which must comprise:

a/ An application made according to Form No. 01 in Appendix XI to this Decree;

b/ A valid copy of the establishment decision or a document containing the name of the medical examination and treatment establishment granted by a competent state agency, for state-owned medical examination and treatment establishments, or of the enterprise registration certificate, for private ones, or of the investment certificate, for foreign-invested ones;

c/ Valid copies of practice certificates of the person responsible for professional and technical operations of the medical examination and treatment establishment and persons taking charge of professional departments of the establishment;

d/ A list of practitioners at the establishment (including practitioners and persons performing medical jobs who are not required to possess a practice certificate) for registration, made according to the form in Appendix IV to this Decree;

dd/ A declaration of facilities, medical equipment, organization and personnel of the establishment, made according to Form No. 02 in Appendix XI to this Decree;

e/ Documents proving that the establishment satisfies the conditions on facilities, medical equipment and organization and personnel corresponding to the scope of professional activity of its form prescribed in Section 1, Chapter III of this Decree;

g/ The charter of organization and operation complying with the form set by the Minister of Health, for state-owned hospitals, or with Form No. 03 in Appendix XI to this Decree, for private hospitals, and the initial operation plan, for hospitals;

h/ A valid copy of the contract on patient transportation, for hospitals and maternity wards without vehicles for external emergency transportation;

i/ A professional and technical list proposed by the establishment on the basis of the professional and technical list issued by the Minister of Health;

k/ For emergency transportation service establishments: a valid copy of the contract on professional support for the hospital. In case of provision of the service of patient transportation abroad, a valid copy of the contract on patient transportation signed with an aviation service company.

2. A dossier of application for an operation license for a medical examination and treatment establishment which changes its form of organization or is split, consolidated or merged must comply with Clause 1 of this Article.

3. A dossier of application for an operation license for a medical examination and treatment establishment which changes its location must comprise:

a/ An application made according to Form No. 04 in Appendix XI to this Decree;

b/ Documents specified in Clause 1 of this Article (if there is any change compared to the dossier for the previous location).

4. A dossier of application for an operation license for a medical examination and treatment establishment which changes its name must comprise:

a/ An application made according to Form No. 05 in Appendix XI to this Decree;

b/ Documents specified in Clause 1 of this Article (if there is any change compared to the previous dossier).

5. A dossier of request for modification of an operation license for a medical examination and treatment establishment which changes the number of patient beds or organizational structure or its scope of professional activity must comply with Clause 3, Article 46 of the Law on Medical Examination and Treatment, which must comprise:

a/ A written request made according to Form No. 06 in Appendix XI to this Decree;

b/ A declaration of facilities, medical equipment, organizations and personnel corresponding to the scale or scope of professional activity to be adjusted, made according to Form No. 02 in Appendix XI to this Decree.

6. A dossier of request for replacement of the person responsible for professional and technical operations of a medical examination and treatment establishment must comprise:

a/ A written request made according to Form No. 07 in Appendix XI to this Decree;

b/ The decision to replace the current person responsible for professional and technical operations of the establishment;

c/ The decision to appoint a new person responsible for professional and technical operations of the establishment;

d/ A valid copy of the practice certificate of the appointed person;

dd/ The labor contract or the recruitment decision of the appointed person;

e/ The written certification of the process of practice for 36 months from the date the practice certificate is granted, made according to Form No. 10 in Appendix XI to this Decree;

g/ The original of the granted operation license of the establishment.

7. A dossier for re-grant of an operation license which is lost or damaged or revoked according to Point a, Clause 1 Article 48 of the Law on Medical Examination and Treatment must comprise:

a/ An application made according to Form No. 08 in Appendix XI to this Decree;

b/ The original of the damaged license (if any).

8. A dossier of announcement of eligibility for performing medical check-ups:

a/ The written announcement made according to Form No. 01 in Appendix X to this Decree;

b/ A valid copy of the granted operation license of the medical examination and treatment establishment;

c/ A list of persons performing medical check-ups, made according to Form No. 02 in Appendix X to this Decree;

d/ A declaration of facilities, medical equipment, organization and personnel of the establishment, made according to Form No. 02 in Appendix XI to this Decree;

dd/ A valid copy of the professional and technical list of the establishment;

e/ A valid copy of the contract on professional support of the hospital (if any).

Article 44. Procedures for grant, re-grant and modification of operation licenses and replacement of persons responsible for professional and technical operations of medical examination and treatment establishments, announcement of eligibility for performing medical check-ups

1. A dossier for grant, re-grant or modification of an operation license or replacement of the person responsible for professional and technical operations of a medical examination and treatment establishment specified in Article 43 of this Decree shall be made in 1 set and sent to:

a/ The Ministry of Health, for dossiers of medical examination and treatment establishments attached to the Ministry of Health, private hospitals or hospitals attached to other ministries;

b/ Provincial-level Departments of Health, for dossiers of local medical examination and treatment establishments, excluding the establishments specified at Point a of this Clause.

2. Order for consideration of the grant, re-grant or modification of an operation license or replacement of the person responsible for professional and technical operations of a medical examination and treatment establishment:

a/ After receiving a dossier for grant, re-grant or modification of an operation license, the Ministry of Health or the provincial-level Department of Health (below referred to as the dossier-receiving agency) shall:

- If the dossier is submitted directly at the dossier-receiving agency, immediately give the applicant a dossier receipt slip made according to Form No. 09 in Appendix XI to this Decree;

- If the dossier is sent by post, within 3 days after receiving the dossier (according to the coming postmark), send a dossier receipt slip to the applicant made according to Form No. 09 in Appendix XI to this Decree.

b/ If the dossier is valid, the dossier-receiving agency shall consider the grant, re-grant or modification of the operation license within 60 days, for hospitals, or 45 days, for other types of medical examination and treatment establishments, counting from the date written on the dossier receipt slip. If refusing to grant, re-grant or modify the operation license, the dossier-receiving agency shall issue a written reply clearly stating the reason.

c/ If a dossier of application for an operation license is invalid:

- Within 10 working days from the date written on the dossier receipt slip, the dossier- receiving agency shall send a written notice to the applicant requesting completion of the dossier. Such notice must specify the documents to be supplemented and contents to be modified;

- After receiving the written request for completion of the dossier, the applicant shall comply with the request and send the modified dossier to the dossier-receiving agency;

- After 10 working days from the date of receiving the modified dossier, the dossier-receiving agency shall, if not requesting further modification or supplementation to the dossier, grant, re-grant or modify the operation license within the period specified at Point b of this Clause; if refusing to do so, it shall issue a written reply clearly stating the reason;

- After 60 days from the date of receiving the request from the dossier-receiving agency, if the applicant fails to comply with the request, it shall re-carry out the relevant procedures for grant, re-grant or modification of the operation license.

3. An operation license shall be granted by the Minister of Health or the director of the provincial-level Department of Health according to the form in Appendix XII. The serial number of the operation license must be pursuant to the table in Form No. 04 in Appendix III to this Decree.

4. Procedures for announcement of eligibility for performing medical check-ups:

Before performing medical check-ups for the first time, a medical examination and treatment establishment shall send (directly or by post) an announcement of eligibility for performing medical check-ups according to Clause 8, Article 43 of this Decree to a state management agency in charge of health. Specifically as follows:

a/ For medical examination and treatment establishments attached to the Ministry of Health, the dossier shall be sent to the Agency of Health Examination and Treatment, the Ministry of Health;

b/ For medical examination and treatment establishments under the management of the Ministry of Public Security, the dossier shall be sent to the Health Administration, the Ministry of Public Security; for medical examination and treatment establishments under the management of the Ministry of Transport, the dossier shall be sent to the Transport Health Administration, the Ministry of Transport;

c/ For medical examination and treatment establishments under the management of provincial-level Departments of Health (excluding the medical examination and treatment establishments specified at Points a and b of this Clause), the dossier shall be sent to the provincial-level Department of Health of the locality where the medical examination and treatment establishment is located.

5. Order of processing dossiers of declaration of eligibility for performing medical check-ups:

a/ When receiving a dossier of declaration of eligibility for performing check-ups, the agency in charge of state management of health defined in Clause 4 of this Article (below referred to as dossier-receiving agency) shall send to the medical examination and treatment establishment announcing its eligibility for performing check-ups a dossier receipt slip made according to Form No. 3 in Appendix X to this Decree. If the dossier is incomplete or invalid as prescribed in Clause 8, Article 43, the dossier-receiving agency shall send to medical examination and treatment establishment a written request for completion of the dossier. After the medical examination and treatment establishment completes the dossier, the dossier-receiving agency shall send to the establishment a dossier receipt slip made according to Form No. 3 in Appendix X to this Decree;

b/ If the dossier is complete and valid as prescribed in Clause 8, Article 43 and the dossier-receiving agency does not request supplementation or modification, after 15 working days from the date of receiving the dossier receipt slip, the medical examination and treatment establishment may perform medical check-ups according to the declared scope of professional activity.;

c/ If the medical examination and treatment establishment which has announced its eligibility for performing medical check-ups changes its name, address, facilities, personnel and/or scope of professional activity which have been announced, it shall send a written notice thereof to the agency that has received the announcement dossier.

Article 45. Organization of appraisal for grant, re-grant and modification of operation licenses for medical examination and treatment establishments

1. The Minister of Health or directors of provincial-level Departments of Health may establish appraisal teams to serve the grant, re-grant or modification of operation licenses for medical examination and treatment establishments according to their competence.

2. The appraisal team shall conduct appraisal within the time limit specified at Point b, Clause 2, Article 44 of this Decree and make a written record thereof according to the form in Appendix XIII to this Decree.

A written record of appraisal of a medical examination and treatment establishment under the management of the Minister of Health shall be made in 3 copies, 1 to be filed at the Ministry of Health, 1 at the provincial-level Department of Health of the locality where the medical examination and treatment establishment is located, and 1 at the medical examination and treatment establishment.

A written record of appraisal of a medical examination and treatment establishment under the management of the director of a provincial-level Department of Health shall be made in 2 copies, one to be filed at the provincial-level Department of Health and the other at the medical examination and treatment establishment.

3. Management of operation licenses:

a/ Each medical examination and treatment establishment shall be granted only one operation license. If a medical examination and treatment establishment has more than one place of operation, each place must satisfy the conditions specified in Article 23 of this Decree and be granted one operation license;

b/ A valid copy of the operation license and the dossier for grant, re-grant or modification of the operation license shall be filed at the operation license-granting agency;

c/ After granting, re-granting or modifying the operation license for a medical examination and treatment establishment, the agency which has granted the operation license shall carry out the following procedures:

- Within 30 days after the grant, re-grant or modification of the operation license, the Ministry of Health shall send a written notice to the provincial-level People’s Committee and provincial-level Department of Health of the locality where the medical examination and treatment establishment is located;

- Within 30 days from the date of grant, re-grant or modification of the operation license, the provincial-level Department of Health shall send a written notice to the People’s Committee and the Health Section of the district, town or provincial city where the medical examination and treatment establishment is located;

- The Ministry of Health shall post the list of medical examination and treatment establishments having their operation licenses granted, re-granted or modified which are under its management on its website. A provincial-level Department of Health shall post the list of medical examination and treatment establishments having their operation licenses granted, re-granted or modified which are under its management on its website.

Chapter IV

ONLINE GRANT OF PRACTICE CERTIFICATES AND MEDICAL OPERATION LICENSES

Article 46.Requirements on dossiers for online registration, grant or re-grant of practice certificates, online grant, re-grant or modification of medical operation licenses

A dossier for online registration, grant or re-grant of a practice certificate, online grant, re-grant or modification of a medical operation license (below referred to as online dossier) shall be considered valid if it satisfies the following conditions:

1. Comprising all documents with complete contents as required for paper documents which are converted into electronic files. Electronic files shall be named according to those of paper documents.

2. Information serving online registration, grant or re-grant of a practice certificate or online grant, re-grant of a medical operation license shall be inputed sufficiently and accurately according to the information in the originals.

Article 47.Procedures for online registration

1. An applicant or his/her at-law representative shall declare information, download the e-documents and confirm the submission of an online dossier with a digital signature and pay a fee according to the procedures posted on the e-portal of the Ministry of Health or the website of the provincial-level Department of Health.

If the applicant does not use a digital signature to confirm the submission of a dossier, it shall send the scanned copies of the paper dossier to the dossier-receiving agency through the registration system for comparison.

2. When the dossier has been sent online as registered, the dossier-receiving agency shall send a dossier receipt slip to the applicant.

3. The dossier-receiving agency shall carry out the administrative procedures in accordance with the relevant provisions of Chapters II and III of this Decree.

4. The result of the online administrative procedures must be a written document bearing a signature of the dossier-receiving agency or an electronic file bearing a digital signature confirming the receipt of the dossier and have legal validity equivalent to that of the normal administrative procedures.

5. The Minister of Health shall provide guidance on the grant and re-grant of practice certificates or grant, re-grant and modification of medical operation licenses which are applied for online.

Article 48. Storage of online dossiers

1. If the dossier is sent online, the applicant shall store the paper dossier to serve inspection and authentication in case of necessity.

2. If documents in the dossier referred to in Clause 1 of this Article is lost or damaged, the applicant and the dossier-receiving agency shall carry out the following procedures:

a/ The applicant shall send a written notice to the dossier-receiving agency and complete the dossier; send another written notice to the dossier-receiving agency when the dossier has been completed; only update the dossier after obtaining approval of the dossier-receiving agency;

b/ Within 60 days after the dossier-receiving agency is notified of the loss of the dossier, if the applicant fails to send a written notice of the completion of the dossier, the dossier-receiving agency shall remove the information posted on the e-portal of the Ministry of Health or the website of the provincial-level Department of Health which is relevant to the granted practice certificate or medical operation license;

c/ The granted practice certificate or medical operation license shall be revoked;

d/ The practitioner may not continue practicing or the medical examination and treatment establishment may not continue operating from the time the dossier-receiving agency removes the information as prescribed at Point b, Clause 2 of this Article.

Chapter V

IMPLEMENTATION PROVISIONS

Article 49.Effect

1. This Decree takes effect on July 1, 2016.

2. Article 3 of the Government’s Decree No. 87/2011/ND-CP of September 27, 2011, detailing a number of articles of the Law on Medical Examination and Treatment, ceases to be effective on the effective date of this Decree. All previous regulations which are contrary to this Decree shall be annulled.

Article 50.Transitional provisions

1. An applicant for grant or re-grant of a practice certificate or grant, re-grant or modification of an operation license before the effective date of this Decree shall comply with legal documents promulgated before the effective date of this Decree.

2. An individual or organization that has provided cosmetological services specified in Clause 1, Article 37, and massage services specified in Article 38, of this Decree must, within 12 months from the date this Decree takes effect, fully satisfy the conditions and the procedures prescribed in this Decree.

3. Occupational disease clinics; clinics of HIV/AIDS examination and treatment; clinics of dietetics and clinics for drug rehabilitation operating before the effective date of this Decree may continue their operation and shall complete the procedures for grant of an operation license before June 30, 2017.

4. Denture prosthesis service establishments regulated in legal documents on private medicine and pharmacy practice and operating before the effective date of this Decree shall be granted an operation license only when satisfying the following conditions:

a/ Facilities:

- Having a fixed location;

- Satisfying the conditions on hospital waste disposal and fire prevention and fighting as prescribed by law;

- Ensuring sufficient electricity and water and other conditions for patient care;

- A dental and denture prosthesis room must have an area of at least 10 m²;

- A denture prosthesis room must have an area of at least 10 m² or is rent under a contract from another denture prosthesis establishment.

b/ Medical equipment: Having sufficient medical equipment and instruments suitable to the registered scope of professional activity.

c/ Personnel: The person in charge of professional aspects must be a tooth implanter having practiced from 1980 or earlier (other entities are not accepted) with a certificate granted by a commune-level People’s Committee according to the form in Appendix XIV to this Decree, and a certificate of eligibility for practice or a denture prosthesis service operation license as prescribed by the law on private medicine and pharmacy practice.

Article 51.Implementation responsibility

1. The Minister of Health shall guide the implementation of this Decree.

2. Ministers, heads of ministerial-level agencies, heads of government-attached agencies and chairpersons of provincial-level People’s Committees shall implement this Decree.-

On behalf of the Government
Prime Minister
NGUYEN XUAN PHUC

 * All appendices to this Decree are not translated.