Circular No. 41/2011/TT-BYT dated November 14, 2011 of the Ministry of Health guiding the grant of practice certificates to medical examination and treatment practitioners and operation licenses to medical examination and treatment establishments

THE MINISTRY OF HEALTH

Circular No. 41/2011/TT-BYT of November 14, 2011, guiding the grant of practice certificates to medical examination and treatment practitioners and operation licenses to medical examination and treatment establishments

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

Pursuant to the Government’s Decree No. 87/2011/ND-CP of September 27, 2011, detailing and guiding a number of articles of the Law on Medical Examination and Treatment;

Pursuant to the Government’s Decree No. 188/2007/ND-CP of December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

The Ministry of Health guides the grant of practice certificates to medical practitioners and operation licenses to medical examination and treatment establishments, as follows:

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular guides:

1. The grant and re-grant of practice certificates to medical examination and treatment practitioners (below referred to as practitioners), covering:

a/ Dossiers and procedures for grant and re-grant of medical examination and treatment practice certificates (below referred to as practice certificates);

b/ Certification of practicing period;

c/ Criteria for recognition of proficiency in Vietnamese or good command of another language or qualification for interpreting in medical examination and treatment;

d/ Organization of the grant and re-grant of practice certificates.

2. Grant, re-grant or modification of operation licenses for medical examination and treatment establishments, covering:

a/ Specific conditions for grant of operation licenses to medical examination and treatment establishments of each organizational form ;

b/ Competence, dossiers and procedures for grant and re-grant of operation licenses to medical examination and treatment establishments;

c/ Organization of the grant, re-grant and modification of operation licenses for medical examination and treatment establishments.

Article 2. Subjects of application

This Circular applies to medical examination and treatment practitioners and establishments nationwide, except those managed by the Ministry of National Defense.

Article 3. Interpretation of terms

1. Medical examination and treatment period required for obtaining a practice certificate is a period during which a person directly examines and treats diseases or cares for patients, counting from the date he/she starts conducting medical examination and treatment after obtaining a professional diploma (the date of signing a labor contract or obtaining a recruitment decision) to the date of application for a practice certificate (including the period of specialty study or postgraduate study in the specialty in which he/she applies for a practice certificate).

2. Medical examination and treatment period required for being appointed as a person in charge of professional and technical operation or the head of a department, section or professional division (below collectively referred to as department) is a period during which a person directly examines and treats diseases or cares for patients, counting from the date he/she starts conducting medical examination and treatment after obtaining a professional diploma (the date of signing a labor contract or obtaining a recruitment decision) to the date of being appointed or assigned as a person in charge of professional and technical operation or the head of a department (including the period of specialty study or postgraduate study in the specialty in which he/she is appointed or assigned).

3. Full-timers are persons working in the whole operation timeframe registered by their medical examination and treatment establishment, for example:

- For a hospital that has registered its operation timeframe of 24 hours a day and 7 days a week, a full-timers must work for full administrative operation hours of this hospital, except his/her days off, public holidays and on-duty time;

- For a general clinic that has registered its operation time frame of 8:00 - 16:00 hours a day and 7 days a week, a full-timer must work from 8:00 hours to 16:00 hours everyday, except his/her days off and public holidays.

Article 4. Principles of guidance and application of laws

1. This Circular guides articles, clauses and points of the Law on Medical Examination and Treatment and the Government’s Decree No. 87/2011/ND-CP of September 7, 2011, detailing and guiding a number of articles of the Law on Medical Examination and Treatment (below referred to as Decree No. 87/2011/ND-CP), which the Minister of Health is assigned to guide, and other issues related to the grant and re-grant of practice certificates to practitioners; grant, re-grant and modification of operation licenses for medical examination and treatment establishments.

2. In addition to the Law on Medical Examination and Treatment, Decree No. 87/2011/ND-CP and this Circular, medical examination and treatment practitioners and establishments shall comply with the laws on pharmaceuticals, trade, enterprises, investment, advertisement and other relevant laws.

3. The collection and use of fees for the grant and re-grant of practice certificates; grant, re-grant and modification of operation licenses for medical examination and treatment establishments; grant of certificates of proficiency in Vietnamese or good command of another language or qualification for interpreting in medical examination; grant of licenses for educational institutions qualified for testing and accrediting proficiency in Vietnamese or good command of another language or qualification for interpreting in medical examination and treatment comply with the Ministry of Finance’s regulations.

Chapter II

GRANT AND RE-GRANT OF PRACTICE CERTIFICATES

Section 1

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

Article 5. Dossiers of application for grant or re-grant of practice certificates for Vietnamese

1. A dossier of application for a practice certificate for a Vietnamese complies with Clause 1, Article 27 of the Law on Medical Examination and Treatment, comprising:

a/ An application for a practice certificate, made according to form No. 01 provided in Appendix 1 to this Circular, and with two 4 cm x 6 cm photos of the applicant with a white background taken within 6 months before the date of application filing;

b/ A certified copy of a diploma or a certificate of professional qualifications for galenic physicians , or a certificate of a family remedy or treatment method granted by the Minister of Health or the director of the Health Department of a province or centrally run city (below referred to as provincial-level Health Department);

c/ A certificate of practicing period;

d/ A resume certified by the People’s Committee of the commune, ward or township (below referred to as commune-level People’s Committee) in which the applicant resides, or of the head of the unit in which the applicant works;

e/ A judicial record card (applicable only when the Minister of Justice issues guidance on the implementation of the Law on Judicial Records).

2. A dossier of application for re-grant of a practice certificate for a person who has a lost or damaged practice certificate or has had it revoked under Points a and b, Clause 1, Article 29 of the Law on Medical Examination and Treatment, comprises: An application for re-grant of a practice certificate, made according to form No. 01 provided in Appendix 2 to this Circular, and two 4 cm x 6 cm photos with a white background taken within 6 months before the date of application filing.

3. A dossier of application for re-grant of a practice certificate for a person who has his/her practice certificate revoked under Points c, d, e, f and g, Clause 1, Article 29 of the Law on Medical Examination and Treatment, comprises:

a/ An application for a practice certificate, made according to form No. 02 provided in Appendix 2 to this Circular, and two 4 cm x 6 cm photos of the applicant with a white background taken within 6 months before the date of application filing;

b/ The papers specified in Clause 1 of this Article, except the certificate of practicing period;

c/ A certificate of continuous updating of medical knowledge as prescribed by the Ministry of Health.

Article 6. Dossiers of application for grant or re-grant of practice certificates for foreigners and overseas Vietnamese

1. A dossier of application for a practice certificate for a foreigner or an overseas Vietnam complies with Clause 2, Article 27 of the Law on Medical Examination and Treatment, comprising:

a/ An application for a practice certificate, made according to form No. 02 provided in Appendix 1 to this Circular, and two 4 cm x 6 cm photos of the applicant with a white background taken within 6 months before the date of application filing;

b/ A certified copy of a professional diploma;

c/ A certificate of practicing period;

d/ A certified copy of a certificate of proficiency in Vietnamese.

In case the applicant has no certificate of proficiency in Vietnamese, he/she must have an interpreter to interpret his/her registered language into Vietnamese.

In case the applicant registers a language other than his/her mother tongue for use in medical examination and treatment, he/she must have a certificate of good command of such language and an interpreter to interpret such language into Vietnamese.

An interpreter must have a certificate of qualification for interpreting the language registered by foreigners for use in medical examination and treatment and a labor contract signed with the medical examination and treatment establishment in which foreigners work;

e/ A certified copy of a work permit granted by a competent Vietnamese state agency in charge of labor;

f/ In case the papers specified at Points b, c and d, Clause 1 of this Article are granted by foreign organizations, they must be consularly legalized and translated into Vietnamese. Their Vietnamese translations must be certified under Vietnamese law.

2. A dossier of application for re-grant of a practice certificate for a foreigner or an overseas Vietnamese who has a lost or damaged practice certificate or has had it revoked under Points a and b, Clause 1, Article 29 of the Law on Medical Examination and Treatment, comprises: An application for re-grant of a practice certificate, made according to form No. 03 provided in Appendix 2 to this Circular, and two 4 cm x 6 cm photos of the applicant with a white background taken within 6 months before the date of application filing.

3. A dossier of application for re-grant of a practice certificate for a foreigner or an overseas Vietnam, who has had his/her practice certificate revoked under Points c, d, e, f and g, Clause 1, Article 29 of the Law on Medical Examination and Treatment, comprises:

a/ An application for re-grant of a practice certificate, made according to form No. 03 provided in Appendix 2 to this Circular, and two 4 cm x 6 cm photos of the applicant with a white background taken within 6 months before the date of application filing;

b/ The papers specified at Points b, c, d, e and f, Clause 1 of this Article.

Article 7. Procedures for grant or re-grant of practice certificates

1. A dossier of application for grant or re-grant of a practice certificate under Article 5 or 6 of this Circular shall be filed as follows:

a/ The applicant for a practice certificate to be granted or re-granted under the competence defined in Clause 1, Article 26 of the Law on Medical Examination and Treatment shall send a dossier set to the Medical Examination and Treatment Management Department of the Ministry of Health;

b/ The applicant for a practice certificate to be granted or re-granted under the competence defined in Clause 2, Article 26 of the Law on Medical Examination and Treatment shall send a dossier set to the provincial-level Health Department.

2. Procedures for considering an application for grant or re-grant of a practice certificate

a/ After receiving the dossier, the Ministry of Health or the provincial-level Health Department (below collectively referred to as the dossier-receiving agency) shall send to the applicant a dossier receipt made according to the form provided in Appendix 3 to this Circular;

b/ Within the time limit specified in Clause 2 or 3, Article 28 of the Law on Medical Examination and Treatment, counting from the date indicated in the dossier receipt, the secretariat defined in Article 9 of this Circular shall examine the dossier. If no supplementation is needed, the dossier shall be submitted to the head of the dossier-receiving agency for grant or re-grant of a practice certificate. In case of refusal to grant or re-grant, a written reply must be issued, clearly stating the reason;

c/ In case the dossier is invalid, the dossier-receiving agency shall, within 10 working days after the date indicated in the dossier receipt, notify such in writing to the applicant for completion of the dossier. A written notice of dossier invalidity must specify the documents which must be added or the contents which must be modified;

d/ Upon receiving a written request  for dossier completion, the applicant shall modify and supplement the dossier according to the contents stated in the request and then send the supplemented dossier to the dossier-receiving agency. The date of receipt of the supplemented dossier shall be indicated in the dossier receipt. If the dossier-receiving agency does not request in writing any modification or supplementation of the dossier, it shall grant or re-grant a practice certificate within the time limit specified at Point b, Clause 2 of this Article;

e/ In case the applicant has supplemented the dossier but it still fails to satisfy requirements, the dossier-receiving agency shall notify such to the applicant for completing the dossier under Points c and d, Clause 2 of this Article.

3. Practice certificates granted or re-granted by the Minister of Health or provincial-level Health Department directors shall be made according to the form provided in Appendix 4, and have codes under Appendix 5 to this Circular. Each individual may be granted only one practice certificate. Blank practice certificates shall be managed and supplied by the Ministry of Health.

4. Copies of practice certificates and dossiers of application for grant or re-grant of practice certificates shall be preserved at granting agencies.

Section 2

ORGANIZATION OF THE GRANT OR RE-GRANT OF PRACTICE CERTIFICATES

Article 8. Advisory councils for grant or re-grant of practice certificates

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

2. The chairpersons of an advisory council shall direct the elaboration of operation regulations of the council for submission to the Minister of Health or the provincial-level Health Department director for approval.

3. Members of an advisory council shall perform tasks assigned by the council chairperson and may be provided with documents related to the performance of the tasks specified in Clause 4, Article 28 of the Law on Medical Examination and Treatment.

Article 9. Secretariat for examination of dossiers of application for grant or re-grant of practice certificates

1. The Minister of Health shall form a secretariat to assist him/her in examining dossiers of application for grant or re-grant of practice certificates, which is composed of:

a/ A representative of the leadership of the Medical Examination and Treatment Management Department, as its head;

b/ A representative of the leadership of the Traditional Medicine and Pharmacy Department, as its deputy head;

c/ A representative of the Legal Department;

d/ A representative of the Science and Training Department;

e/ Other related persons.

2. The director of a provincial-level Health Department shall form a secretariat to assist him/her in examining dossiers of application for grant or re-grant of practice certificates, which is composed of:

a/ The head of the practice management section or the medical operation section (for provincial-level Health Departments having no practice management section), as its head;

b/ A representative of the medical operation section (for provincial-level Health Departments having the practice management section);

c/ A representative of the organization and personnel section of the provincial-level Health Department;

c/ Other related persons.

3. A secretariat has its standing body based at the Medical Examination and Treatment Management Department of the Ministry of Health or at the practice management section or the medical operation section (for provincial-level Health Departments having no practice management section) of the provincial-level Health Department.

Article 10. Working relationship between the advisory council and secretariat

1. The secretariat shall:

a/ Ask for advice of the advisory council in case of necessity on issues related to the grant, re-grant or revocation of practice certificates; suspension of professional activities of practitioners; consideration and recognition of certificates of continuous updating of medical knowledge or papers for certification of proficiency in Vietnamese or good command of another language or qualification for interpreting in medical examination and treatment;

b/ Biannually report to the advisory council on lists of persons who are granted or re-granted practice certificates or have their practice certificates revoked and persons suspended from professional activities.

2. The advisory council shall:

a/ Give advice when asked by the secretariat on the issues specified at Point a, Clause 1 of this Article;

b/ Notify the secretariat of cases in which it has clear grounds to believe that the grant, re-grant or revocation of practice certificates or the suspension of professional activities of practitioners is unlawful.

Section 3

REGISTRATION OF MEDICAL EXAMINATION AND TREATMENT PRACTICE

Article 11. Principles of practice registration

1. A practitioner may register to take charge of professional and technical activities of only one medical examination and treatment establishment, and may not concurrently take charge of professional and technical activities of two or more medical examination and treatment establishments.

2. A practitioner may register to manage only one department of a medical examination and treatment establishment (he/she may neither concurrently manage two or more departments of a medical examination and treatment establishment nor concurrently manage a department of another medical examination and treatment establishment).

3. A practitioner who takes charge of professional and technical activities of a medical examination and treatment establishment may concurrently manage a department of the same establishment, provided this post is relevant to his/her  professional training major.

4. A practitioner in a medical examination and treatment establishment may register to take charge of professional and technical activities of another medical examination and treatment establishment which operates outside his/her office hours.

5. A practitioner in a state-owned medical examination and treatment establishment may not register to act as the head of a private hospital or a medical examination and treatment establishment founded and operating under the Law on Enterprises or the Law on Cooperatives, unless he/she is appointed by a competent state agency to participate in managing a partly state-owned medical examination and treatment establishment.

6. A practitioner who has registered to take charge of professional and technical activities of a medical examination and treatment establishment may register to work outside his/her office hours for another medical examination and treatment establishment in the same province or city, provided the total extra working time does not exceed 200 hours under the Labor Code.

7. A practitioner who has registered to practice in a medical examination and treatment establishment may not register to take charge of professional and technical activities of a medical examination and treatment establishment in another province or city, in order to assure the continuity and stability of his/her medical examination and treatment.

8. A practitioner who has registered to practice in a medical examination and treatment establishment, when conducting medical examination and treatment under the regime of rotation of personnel from higher levels to lower levels, or for the humanitarian purpose, or performing professional techniques (for example, holding a consultation or performing a surgical operation) under contracts between medical examination and treatment establishments, is not required to make practice registration.

Article 12. Contents and form of registration of medical examination and treatment practice

1. Contents of practice registration:

a/ Practice place: Name and address of the medical examination and treatment establishment where the practitioner registers to practice;

b/ Practice time: Working time at the medical examination and treatment establishment (number of hours a day and days a week);

c/ Professional position:

- Department, section or professional division where the practitioner works;

- Post which the practitioner is assigned to hold (for example, head or person in charge of professional and technical activities or manager of a department, or a medical staff).

2. Form of practice registration: Practice registration shall be made in writing according to the form provided in Appendix 6 to this Circular.

Article 13. Procedures for practice registration

1. Time of practice registration:

a/ For a medical examination and treatment establishment applying for an operation license, it shall make practice registration for its practitioners simultaneously with filing the application for an operation license;

b/ For a medical examination and treatment establishment already having an operation license, within 10 working days after signing decisions on recruitment of or labor contracts with practitioners or sacking practitioners or terminating labor contracts with practitioners or a practitioner notifies his/her resignation, it shall send a list of newly recruited practitioners and a list of practitioners who no longer work in the establishment to a competent state management agency defined in Clause 2 of this Article.

2. Receipt of written registrations of practice:

a/ Provincial-level Health Departments shall receive practice registrations of medical examination and treatment establishments located in their respective localities (including private hospitals and medical examination and treatment establishments under ministries and sectors), except those attached to the Ministry of Health;

b/ The Ministry of Health shall receive practice registrations of its attached medical examination and treatment establishments.

3. Certification of practice registration:

a/ For a medical examination and treatment establishment applying for an operation license, the certification of practice registration must be expressed in a written record of appraisal;

b/ For an operating medical examination and treatment establishment, within 10 working days after receiving a list of practitioners for practice registration specified in Clause 1 of this Article, the Minister of Health or the provincial-level Health Department director shall, based on the practice registration principles provided in Article 11 of this Circular, approve in writing the practice registration. In case of disapproval, a written reply must be issued, clearly stating the reason.

4. In case there is on the list of to be-registered practitioners of a medical examination and treatment establishment a practitioner who is practicing in another one, the working time and place and professional position of such practitioner in this establishment must be indicated in the list

Article 14. Management of practice registration information

1. Within 10 working days after approving the practice registration of practitioners, the provincial-level Health Department shall send a list of practitioners registered in its locality to the Ministry of Health.

2. Within 10 working days after approving the practice registration of practitioners, the Ministry of Health shall send a list of registered practitioners to the provincial-level Health Department of the locality in which the medical examination and treatment establishment employing these registered practitioners is located.

Section 4

CERTIFICATION OF PRACTICING PERIOD

Article 15. Principles of registration for practicing activities

A practice certificate applicant shall register for practicing activities relevant to his/her professional training major.

General doctors shall register for practicing activities in one of the four specialties: internal medicine, surgery, obstetrics and pediatrics or either of the systems of internal medicine - pediatrics or surgery - obstetrics. For practicing activities by system, the total period of practicing activities must be 18 months, including at least 9 consecutive months for each specialty in the system.

General assistant doctors shall register for practicing activities in one of the four specialties: internal medicine, surgery, obstetrics and pediatrics or either of the systems of internal medicine - pediatrics or surgery - obstetrics. For practicing activities by system, the total period of practicing activities must be 12 months, including at least 6 consecutive months for each specialty in the system.

Article 16. Certification of practicing period

1. Certification of practicing period for doctors:

a/ For a doctor who starts conducting medical examination and treatment before January 1, 2012:

- If he/she has conducted medical examination and treatment for at least 18 consecutive months in medical examination and treatment establishments, he/she may obtain certification of adequate practicing period;

- If he/she has conducted medical examination and treatment for less than 18 consecutive months in medical examination and treatment establishments, his/her period of conducting medical examination and treatment before January 1, 2012, shall be counted as his/her practicing period (counting from the date of signing a labor contract or obtaining a recruitment decision). He/she shall continue practicing till this period reaches full 18 months in order to obtain certification of adequate practicing period;

- If he/she has conducted medical examination and treatment for at least 18 months in medical examination and treatment establishments but later has ceased conducting medical examination and treatment for 2 years by the date of filing an application for a practice certificate and has a certificate of continuous updating of medical knowledge, he/she is not required to conduct practicing activities again. In case he/she has no certificate of continuous updating of medical knowledge, he/she shall conduct practicing activities under Clause 1, Article 24 of the Law on Medical Examination and Treatment;

b/ Doctors who start conducting medical examination and treatment from January 1, 2012 onward, shall conduct practicing activities under Clause 1, Article 24 of the Law on Medical Examination and Treatment.

2. Certification of practicing period for assistant doctors:

a/ For an assistant doctor who starts conducting medical examination and treatment before January 1, 2012:

- If he/she conducts medical examination and treatment for at least 12 consecutive months in medical examination and treatment establishments, he/she may obtain certification of adequate practicing period;

- If he/she conducts medical examination and treatment for less than 12 consecutive months in medical examination and treatment establishments, his/her period of conducting medical examination and treatment before January 1, 2012, shall be counted as his/her practicing period (counting from the date of signing a labor contract or obtaining a recruitment decision), and he/she shall continue conducting practicing activities till his/her practicing period reaches full 12 months in order to obtain certification of adequate practicing period;

- If he/she had conducted medical examination and treatment for at least 12 months in medical examination and treatment establishments but later has ceased conducting medical examination and treatment for 2 years by the date of filing an application for a practice certificate, he/she shall conduct practicing activities under Clause 1, Article 24 of the Law on Medical Examination and Treatment;

b/ Assistant doctors who start conducting medical examination and treatment from January 1, 2012 onward shall conduct practicing activities under Clause 1, Article 24 of the Law on Medical Examination and Treatment.

3. Certification of practicing period for midwives, technicians and sanatorium nurses:

a/ For a midwife, technician or sanatorium nurse who starts conducting medical examination and treatment before January 1, 2012:

- If he/she has conducted medical examination and treatment for at least 9 consecutive months in medical examination and treatment establishments, he/she may obtain certification of adequate practicing period;

- If he/she has conducted medical examination and treatment for less than 9 consecutive months in medical examination and treatment establishments, his/her period of conducting medical examination and treatment before January 1, 2012, shall be counted as his/her practicing period (counting from the date of signing a labor contract or obtaining a recruitment decision), and he/she shall continue conducting practicing activities till his/her practicing period reaches full 9 months in order to obtain certification of adequate practicing period;

- If he/she has conducted medical examination and treatment for at least 9 months in medical examination and treatment establishments but later has ceased conducting medical examination and treatment for 2 years by the date of filing an application for a practice certificate, he/she shall conduct practicing activities under Clause 1, Article 24 of the Law on Medical Examination and Treatment.

b/ Midwives, technicians and sanatorium nurses who start conducting medical examination and treatment from January 1, 2012 onward, shall conduct practicing activities under Clause 1, Article 24 of the Law on Medical Examination and Treatment.

4. The Minister of Health or provincial-level Health Department directors shall assign medical examination and treatment establishments under their management to guide practicing activities of persons wishing to have their practicing periods certified.

Article 17. Contents of certification of professional capacity and ethics

1. Subject to certification of professional capacity is capacity to perform basic professional techniques in medical specialties registered for practicing activities as specified by heads of medical examination and treatment establishments.

2. Subject to certification of professional ethics are performance of the obligations specified in Articles 36, 37, 38 and 39 of the Law on Medical Examination and Treatment and behaviors of practitioners registering for practicing activities as provided in the Minister of Health’s Decision No. 29/2008/QD-BYT of August 18, 2008, promulgating the code of conduct of officials and public employees in non-business health units.

Article 18. Organization of practicing activities

1. Admission of practicing persons:

a/ Practicing persons shall send certified copies of their professional diplomas and applications, made according to the form provided in Appendix 7 to this Circular, to medical examination and treatment establishments where they register for practicing activities;

b/ Heads of medical examination and treatment establishments shall issue decisions to admit practicing persons and assign practicing instructors, made according to the form provided in Appendix 8 to this Circular. In case a person registers for practicing activities is not an employee of a medical examination and treatment establishment, a contract must be signed between them according to the form provided in Appendix 9 to this Circular.

2. Practicing instructors must be engaged in professional operations relevant to medical specialties in which practicing persons register for practicing activities.

3. Practicing instructors shall guide practicing persons in conducting medical examination and treatment. They shall take responsibility for results of medical examination and treatment conducted by practicing persons during the practicing period.

4. At the end of the practicing period, practicing instructors shall give remarks on the performance of registered practicing persons according to the contents specified in Article 17 of this Circular and take responsibility for their evaluation.

5. After obtaining remarks of practicing instructors defined in Clause 3 of this Article, heads of medical examination and treatment establishments shall grant practicing period certificates, made according to the form provided in Appendix 10 to this Circular.

Section 5

CRITERIA FOR RECOGNITION OF PROFICIENCY IN VIETNAMESE OR GOOD COMMAND OF ANOTHER LANGUAGE OR QUALIFICATION FOR INTERPRETING IN MEDICAL EXAMINATION AND TREATMENT

Article 19. Criteria for recognition of practitioners’ proficiency in Vietnamese or good command of another language in medical examination and treatment

1. A practitioner will be recognized as being proficient in Vietnamese in medical examination and treatment after he/she is tested by an educational institution specified in Clause 1, Article 21 of this Circular in all four skills of listening, speaking, reading and writing in Vietnamese, except the cases specified in Clause 3 of this Article.

2. A practitioner will be recognized as having good command of a language other than Vietnamese and his/her mother tongue in medical examination and treatment after he/she is tested by an educational institution specified in Clause 1, Article 21 of this Circular in all four skills of listening, speaking, reading and writing in such language which he/she has registered to use in medical examination and treatment, except the cases specified in Clause 3 of this Article.

3. A practitioner possessing any of the following degrees or certificates is not required to take a test for recognition:

a/ Intermediate or higher-level degree in medicine granted by a domestic or foreign lawful training institution with the whole training program conducted in Vietnamese or a language which the practitioner registers to use in medical examination and treatment;

b/ Certificate of completion of a specialized medicine training course which lasts 12 months or more and is conducted in Vietnamese or a language which the practitioner registers to use in medical examination and treatment;

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

Degrees and certificates specified in Clause 3 of this Article must be those granted within 5 years before the date of dossier filing.

Article 20. Criteria for recognition of qualification for interpreting in medical examination and treatment

1. A person will be recognized as qualified for interpreting in medical examination and treatment when he/she is proficient in all four skills of listening, speaking, reading and writing in a foreign language and after he/she is tested by an educational institution specified in Clause 1, Article 21 of this Circular for recognition of his/her qualification for interpreting in medical examination and treatment, except the cases specified in Clause 2 of this Article.

2. A person possessing any of the following degrees or certificates is not required to take a test for recognition:

a/ Intermediate or higher-level degree in medicine granted by a domestic or foreign lawful training institution with the whole training program conducted in a foreign language;

b/ Certificate of completion of a specialized medicine training courses which lasts 12 months or more and is conducted in a foreign language;

c/ Intermediate or higher-level degree in medicine or folk medicine and foreign-language university degree.

Degrees and certificates specified at Points a and b, Clause 2 of this Article must be those granted within 5 years before the date of dossier filing.

Article 21. Conditions on educational institutions for testing and recognizing proficiency in Vietnamese or good command of another language or qualification for interpreting in medical examination and treatment

1. An educational institution may test and recognize proficiency in Vietnamese or good command of another language or qualification for interpreting in medical examination and treatment when fully satisfying the following conditions:

a/ Being a medicine university;

b/ Having a foreign language faculty or subject;

c/ Having a bank of exam questions for testing and recognizing proficiency in Vietnamese or good command of another language or qualification for interpreting in medical examination and treatment.

2. Dossiers and procedures:

a/ A dossier comprises:

- Certified copies of documents evidencing the establishment and operation of the educational institution;

- A certified copy of the decision to establish the foreign-language faculty or subject group;

- A list of full-time lecturers of the foreign-language faculty or group;

- A bank of exam questions for testing and recognizing proficiency in Vietnamese or good command of another language or qualification for interpreting in medical examination and treatment in any of the following languages: English, French, Russian, Chinese, Arabian, Spanish, German, Japanese and Korean.

b/ Procedures:

- Based on the conditions specified in Clause 1 of this Article, the educational institution shall compile a dossier under Point a, Clause 2 of this Article, then send it to the Ministry of Health (the Science and Training Department) to request recognition of qualification. Particularly, questions and answers of the bank of exam questions may be sent in written form, stored and sent in CD, DVD, USB or by e-mail.

- Within 15 working days after receiving a valid dossier, the Ministry of Health shall give a written permission. In case of refusal to permit, it shall clearly state the reason. When necessary, the Ministry of Health shall conduct a physical inspection at the permit-applying institution before giving permission.

Article 22. Dossiers and procedures for requesting testing or recognition of proficiency in Vietnamese or good command of another language or qualification for interpreting in medical examination and treatment

1. A dossier of request for testing comprises:

a/ An application, made according to the form provided in Appendix 11 to this Circular, and two 4 cm x 6 cm photos of the applicant with a white background taken within at least 6 months before the date of application filing;

b/ A certified copy of the valid identity card or passport.

2. A dossier of request for recognition comprises:

a/ The papers specified at Points a and b, Clause 1 of this Article;

b/ A certified copy of the degree or certificate specified in Clause 3, Article 19 of this Circular, for foreigners or overseas Vietnamese requesting recognition of their proficiency in Vietnamese, or that specified in Clause 2, Article 20 of this Circular, for persons requesting recognition of their qualification for interpreting in medical examination and treatment, or that specified at Point d, Clause 1, Article 6 of this Circular, for practitioners using other languages in medical examination and treatment.

3. Procedures for requesting testing or recognition:

a/ A dossier specified in Clause 1 or 2 of this Article shall be sent to an educational institution specified in Clause 1, Article 21 of this Circular;

b/ Within 30 days after receiving a complete dossier, the educational institution shall:

- Examine the applicant and grant a certificate, for the cases specified in Clauses 1 and 2, Article 19 and Clause 1, Article 20. Examination results must be publicly displayed; or

- Grant a certificate, for the cases specified in Clause 3, Article 19 and Clause 2, Article 20. In case of refusal to grant a certificate, it shall reply in writing, clearly stating the reason.

4. Certificates shall be made according to the form provided in Appendix 12 to this Circular.

Chapter III

CONDITIONS FOR OPERATION OF MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Section 1

SPECIFIC CONDITIONS FOR GRANTING OPERATION LICENSES FOR MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS OF DIFFERENT ORGANIZATIONAL FORMS

Article 23. Conditions for granting operation licenses for 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 high-tech ophthalmologic hospital must have at least 10 patient beds.

2. Physical foundation:

a/ A hospital must be designed and built according to Vietnam construction standard 365:2007. Particularly, the designing and building of emergency, intensive-care and anti-toxic, operation, image diagnosis and testing departments must strictly comply with the Minister of Health’s Decisions Nos. 32, 33 and 34/2005/QD-BYT of October 31, 2005, and No. 35/2005/QD-BYT of November 15, 2005.

A hospital planned to be built in a district of a centrally run city on a land area which is not large enough as required by Vietnam construction standard 365:2007, may be designed and built into a multi-storied block building satisfying the following conditions:

- Departments, rooms and hallways are arranged conveniently for professional activities after the 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. Hospitals commencing their operation before January 1, 2012, may continue operating but must satisfy the condition of the façade width by January 1, 2016, at the latest.

b/ Satisfying the conditions of radiation safety, hospital waste management, fire prevention and fighting under law;

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

3. Medical equipment:

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

b/ Having sufficient vehicles for internal and external emergency transportation. Hospitals having no vehicles for external emergency transportation must have transportation contracts signed with establishments having such vehicles.

4. Organization:

a/ Departments:

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

- Medical examination department, which has a place for patient reception, first-aid and patient stay rooms, consulting room and minor operation room);

- Para-clinical department, which has at least two units for testing and image diagnosis. Particularly, an ophthalmologic hospital having no image diagnosis unit must have a contract signed with a medical examination and treatment establishment having a licensed image diagnosis unit;

- Pharmaceutical department;

- Other specialized departments and sections, which must be suitable to the scale, functions and tasks of the hospital.

b/ Functional sections of general planning, organization and personnel, convalescence, finance and accounting.

5. Personnel:

a/ The number of full-time practitioners (official staff) in each department must account for at least 50% of the total number of practitioners in this department;

b/ Payroll limits, proportional structure of professional operation sections comply with Clauses 1, 2, 3 and 4, Section II of Joint Circular No. 08/2007/TTLT-BYT-BNV of June 5, 2007, of the Ministry of Health and the Ministry of Home Affairs, guiding non-business payroll limits of state-owned health establishments;

c/ A person in charge of professional and technical activities of a hospital must satisfy the following conditions:

- Being a doctor with a practice certificate relevant to at least one of medical specialties registered by the hospital;

- Having conducted medical examination and treatment for at least 54 months. The assignment or appointment of a person in charge of professional and technical activities of a hospital must be made in writing;

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

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

- Being a doctor with a practice certificate relevant to this specialty;

- Having conducted medical examination and treatment for at least 36 months. The assignment or appointment of a department head must be made in writing;

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

e/ The head of another department must satisfy the following conditions:

- Possessing a university degree and having worked in such department for at least 36 months, counting from the date of receiving the university degree to the date of being assigned or appointed as the department head. The assignment or appointment of a department head must be made in writing;

- Working on a full-time basis in the hospital;

f/ The head of the pharmaceutical department must be a person working on a full-time basis in the hospital and satisfying the conditions specified in Clause 1, Article 7 of the Minister of Health’s Circular No. 22/2011/TT-BYT of June 10, 2011, stipulating the organization and operation of pharmaceutical departments of hospitals;

g/ A surgeon must satisfy the following conditions:

- Being a doctor specialized in surgery or a general doctor possessing a certificate of training in surgery issued by a hospital at provincial or higher level or a medicine university or a training and direction center of a special-grade or grade-1 hospital attached to the Ministry of Health. A surgeon trained overseas must have a specialty certificate;

- Having a written permission for conducting surgery or surgical intervention issued by the hospital director at the request of the person in charge of professional and technical activities of the hospital.

h/ If wishing to conduct medical examination and treatment, persons other than those specified at Points c, d, e, f and g of this Clause working in a hospital must have a practice certificate and may only conduct medical examination and treatment within the scope of assigned jobs. The assignment of jobs to these persons must be made in writing and suitable to the scope of professional activities stated in their practice certificates.

6. Scope of professional activities:

Performing professional techniques in a list approved by the Minister of Health or the provincial-level Health Department director.

Article 24. Conditions for grant of operation licenses for polyclinics

1. Scale of polyclinic:

A polyclinic must have at least the following:

a/ Two of the four specialized departments of internal medicine, surgery, obstetrics and pediatrics;

b/ A first-aid room;

c/ A minor operation room;

d/ A patient stay room;

e/ Para-clinical department, which consists of two units of testing and image diagnosis.

2. Physical foundation:

a/ A polyclinic must have a place for patient reception, a first-aid room, a patient stay room, specialized consulting rooms and a minor operation room. Rooms in a polyclinic must satisfy the following minimum area requirement:

- The first-aid room is at least 12 m2 large;

- The patient stay room is at least 15 m2 large and has 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 consulting rooms and the minor operation room are at least 10 m2 large each.

Particularly, state-owned regional polyclinics must conform to design standards provided in the Minister of Health’s Decision No. 1327/2002/QD-BYT of April 18, 2002.

b/ Satisfying the conditions of radiation safety, hospital waste management and fire prevention and fighting under law;

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

3. Medical equipment:

A polyclinic must have sufficient medical equipment and instruments suitable to the scope of its registered professional operation.

4. Organization and personnel:

a/ The number of full-time doctors (official staff) must account for at least 50% of the total number of doctors of the polyclinic;

b/ A person in charge of professional and technical activities of a polyclinic must satisfy the following conditions:

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

- Having conducted medical examination and treatment for at least 54 months. The assignment or appointment of a person in charge of professional and technical activities of the polyclinic must be made in writing;

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

c/ If wishing to conduct medical examination and treatment, persons other than the person in charge of professional and technical activities of a polyclinic working in the polyclinic must have a practice certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of jobs to these persons must be suitable to the scope of professional activities stated in their practice certificates.

5. Scope of professional activities:

Practicing within the scope of professional activities approved by provincial-level Health Department directors. Approval must be based on the provisions on scope of professional activities of Articles 25, 26, 28, 29, 30, 32, 33 and 34 of this Circular.

Article 25. Conditions for grant of operation licenses for specialized clinics

1. Physical foundations:

a/ Construction and designing:

- A specialized clinic must be in a fixed location and separated from daily-life activities of surrounding households;

- A specialized clinic must be built firmly and well lit, and have dustproof ceilings, walls and floors made of easy-to-clean materials;

b/ A specialized clinic must have medical examination and treatment rooms which are at least 10 m2 large each and a place for patient reception, except rooms for medical examination consulting by phone and rooms for health care consulting via telematic media and medical equipment. Particularly, surgery or cosmetic surgery clinic must have also a patient stay room which is at least 12 m2 large; a functional rehabilitation clinic must have also a functional rehabilitation room which is at least 10 m2 large;

c/ In addition to the conditions specified at Point b, Clause 1 of this Article, depending on the scope of professional activities, a clinic must additionally satisfy the following conditions:

- Having an operation room which is at least 10 m2 large in case the clinic performs operation, including dental implant technique;

- Having a functional probing room which is at least 10 m2 large in case the clinic performs functional probing;

- Having a gynecological examination room which is at least 10 m2 large in case the clinic performs gynecological examination or examination of sexually transmitted diseases;

- Having a room for performance of family planning techniques which is at least 10 m2 large in case the clinic performs family planning techniques;

- Having a room for kinetotherapy which is at least 40 m2 large in case the clinic provides kinetotherapy;

- For an orthodontic clinic having three or more dental chairs, the space for each dental chair must be at least 5 m2;

- Specialized clinics using radiation equipment (including also dental X-ray equipment mounted on dental chairs) must satisfy requirements on radiation safety.

d/ Ensuring medical waste treatment according to law and aseptic operation, implant and family planning rooms;

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

2. Medical equipment:

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

b/ Having anti-shock medicine boxes and sufficient specialized first-aid medicines;

c/ Rooms for medical examination consulting by phone and rooms for health care consulting via telematic media and medical equipment are not required to have medical equipment and instruments specified at Points a and b, Clause 2 of this Article but must have sufficient telematic appliances and equipment suitable to registered consulting activities.

3. Personnel:

a/ A person in charge of professional and technical activities of a specialized clinic must be a doctor having a practice certificate relevant to medical specialties registered by the clinic and having conducted medical examination and treatment for at least 54 months in such specialty.

b/ Apart from the person in charge of professional and technical activities of a specialized clinic, other persons working in this clinic and wishing to conduct medical examination and treatment must have a practice certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of jobs must be suitable to the scope of professional activities stated in their practice certificates;

4. Scope of professional activities:

a/ For general internal medicine clinics and family-doctor clinics:

- First-aid and examination and treatment of common adult diseases other than specialized operations;

- Performance of electrocardiographic, electroencephalographic, electromyographic, cerebral blood-flow measuring, ultrasonic, gastroscopic techniques, provided doctors directly performing these techniques have professional training certificates issued by a hospital at provincial or higher level. In case of performance of gastroscopic technique, a certificate of performance of practicing activities in the specialty for 18 months or more in a medical examination and treatment establishment is also required.

Particularly, family-doctor clinics may conduct health care and medical examination and treatment at patients’ homes.

- Other professional techniques as approved by provincial-level Health Department directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

b/ For specialized clinics in the internal medicine system (cardiovascular system, respiratory system, digestive system, pediatrics and other specialties of internal medicine):

- First-aid, examination and treatment of diseases of internal medicine specialties;

- Other professional techniques as approved by provincial-level Health Department directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

c/ Rooms for medical examination and treatment consulting by phone and rooms for health care consulting via telematic appliances and medical equipment:

- Consulting rooms may provide counseling in their approved medical specialties;

- Practitioners may provide health care counseling relevant to their practice certificates.

d/ For surgery clinics:

- Surgical first-aid and palliation;

- Examination and dressing of common wounds;

- Plaster cast and removal of plaster casts for minor bone fracture;

- Removal of sebaceous cysts and small superficial cysts;

- Non-lancing of big diffuse pyogenic abscess cavities.

- Other professional techniques as approved by provincial-level Health Department directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

e/ For obstetrics-gynecology - family planning clinics:

- Obstetrical and gynecological first-aid;

- Pre-natal checkup and pregnancy management;

- Examination and treatment of common gynecological diseases;

- Placement of vaginal suppositories;

- Cauterization of cervical uterine segment;

- Colposcopy and curettage for detection of precancerous cells;

- Obstetrical ultrasonic techniques, provided doctors directly performing ultrasonic techniques have professional training certificates issued by a hospital at the provincial or higher level and certificates of performance of practicing activities in the specialty for 18 months or more in a medical examination and treatment establishment;

- Placement of intrauterine contraceptive devices;

- Internal vacuum extraction or abortion of fetuses which are up to 6 weeks old (between 36 and 42 days from the first date of the last menstruation), provided the conditions specified in the national standard for reproductive health care services promulgated by the Minister of Health are met;

- Other professional techniques as approved by provincial-level Health Department directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

f/ For dental clinics:

- Examination and treatment of common diseases and first-aid for maxillary and facial wounds;

- Minor operations to prevent scars of facial minor wounds of under 2 cm;

- Temporo-mandibular joint adjustment;

- Superficial laser treatment;

- Treatment of gum (alveolaris) diseases;

- Lancing of tooth abscesses, tartar removing and tooth extraction;

- Dental prosthesis;

- Dental orthopedics;

- Dental care and endodontological treatment;

- Simple implant of one or two teeth per time of manipulation (particularly for submandibular incisors, the maximum number per time of implant is four) provided doctors directly perform the implant technique have dental implant certificates granted by a medicine university or hospital at provincial or higher level. Dental clinics are not allowed to perform cuboid bone grafting for implant or perform implant for patients suffering progressive adult diseases which might affect implant quality;

- Dental minor operation;

- Other professional techniques as approved by provincial-level Health Department directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

g/ For otorhinolaryngologic clinics:

- Examination and treatment of common diseases and otorhinolaryngologic first-aid;

- Treatment of sinusitis, exploratomic sinusal puncture, draining of cystic mucus;

- Incision and lancing of acute otitis media;

- Incision and lancing of tonsillar abscesses;

- Excision of simple polyps, sebaceous cysts, benign cysts and adipoma in the ear, nose and throat;

- Nasal hemostasis;

- Removal of foreign objects from the ear, nose and throat, except those in larynx and esophagus;

- Heat or laser guttural cauterization;

- Adenoidectomy;

- Other professional techniques as approved by provincial-level Health Department directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

h/ For ophthalmologic clinics:

- Examination and treatment of common diseases, ophthalmologic first-aid;

- Subconjunctival and intraocular injection;

- Removal of foreign objects from conjunctiva or cornea, excision of eyelid cysts;

- Cleaning of lacrimal canals;

- Other professional techniques as approved by provincial-level Health Department directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

i/ Cosmetic surgery clinics:

- Creation of dimples, obliteration of supercillary arch tattoos, lifting of supercillary arch, formation of cheekbone, cleft chin or receding chin, reconditioning of facial and neck skin;

- Eyelid, nose, lip and ear re-shaping;

- Cosmetic surgery clinics are not allowed to perform plastic surgery operations of breast augmentation or implant, reduction of mammary areola and nipples; neatening of abdominal wall, buttock and thigh; tightening of facial, buttock and thigh skin; fat removal;

- Other professional techniques as approved by provincial-level Health Department directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

- Cosmetic surgery that would change identity features of persons indicated in their identity cards may be performed only after these persons have filed requests for permission of police departments that have issued their identity cards.

j/ For functional rehabilitation clinics:

- Functional rehabilitation for persons suffering central or peripheral neuroparalysis syndrome or chronic diseases or after undergoing operation;

- Other professional techniques as approved by provincial-level Health Department directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

k/ For mental clinics:

- First-aid, examination and outpatient treatment of mental diseases and epilepsy;

- Providing psychotherapy;

- Other professional techniques as approved by provincial-level Health Department directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

l/ For oncological clinics:

- Examination and early detection of common oncological diseases;

- Collection of swab samples for cytological or pathoanatomic tests of some types of cervical, rectal, vaginal, breast and nodular cancer. Results of cytological or pathoanatomic tests must be concluded by pathoanatomical - cytologic doctors;

- Examination and periodical monitoring of oncological diseases under treatment;

- Other professional techniques as approved by provincial-level Health Department directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

m/ For dermatological clinics:

- Examination and treatment of skin diseases, leprosy and sexually transmitted diseases;

- Other professional techniques as approved by provincial-level Health Department directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

Article 26. Conditions for grant of operation licenses for traditional medicine clinics

1. Physical foundations:

a/ A traditional medicine clinic must satisfy the conditions specified at Points a, d and e, Clause 1, Article 25 of this Circular;

b/ A diagnosis and treatment room must be at least 10 m2 large and have a place for patient reception;

c/ Depending on the scope of its registered professional activities, a traditional medicine clinic must also 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, at least 5 m2 for each bed;

- If providing medicinal sauna (anemopathy), it must have a sauna chamber which is at least 2 m2 large, closed and well-lit;

- If preparing some pre-packaged medicines, it must obtain permission of the provincial-level Health Department after appraisal.

2. Medical equipment:

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

- They must have herb cabinets with medicinal herbs and substances contained in drawers and securely covered bottles or pots with labels showing names of medicinal herbs;

- They must have medicine scales and divide medicinal herbs according to recipes.

b/ For clinics providing acupuncture, massage and acupressure:

- They must have beds for acupuncture, massage and acupressure;

- They must have sufficient tools for acupuncture, massage and acupressure and infrared lamps;

- They must have sufficient tools for and guide the relief of over-acupuncture.

c/ Clinics providing medicinal sauna must have a medicinal steam system;

3. Personnel:

a/ Persons in charge of professional and technical activities of traditional medicine clinics must be doctors or assistant doctors specialized in traditional medicine or have galenic physician certificates granted by the Ministry of Health or provincial-level Health Departments or persons who have family remedies or treatment methods and traditional medical examination and treatment practice certificates;

- Traditional medicine doctors must have conducted medical examination and treatment with traditional medicine for at least 54 months;

- Assistant doctors in traditional medicine must have conducted medical examination and treatment with traditional medicine for at least 48 months;

- Galenic physicians or persons who have handed-down family remedies or treatment methods must have conducted medical examination and treatment with traditional medicine for at least 36 months.

b/ In addition to the person in charge of professional and technical activities of a traditional medicine clinic, other persons working in the clinic and wishing to conduct medical examination and treatment must have a practice certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of these persons to conduct medical examination and treatment must be suitable to the scope of professional activities stated in their practice certificates.

4. Scope of professional activities:

a/ Medical examination and treatment with traditional medicine (with or without medicinal herbs);

b/ Use of finished traditional medicines produced by other establishments which have circulation registrations granted by the Ministry of Health for use in medical examination and treatment;

c/ Preparation of medicinal raw materials into medicinal powders and slices and scaling of medicinal recipes for patients;

d/ Practitioners with handed down family remedies or treatment methods may conduct medical examination and treatment only with these remedies or methods;

e/ Before producing pre-packaged medicines (ointment, pill, pellet or powder) for use by their patients, traditional medicine clinics shall register these medicines with provincial-level Health Departments on their ingredients, production process (enclosed with a description of the physical foundations and equipment), effects, dosages, contraindications and labels. Provincial-level Health Departments shall consider, appraise and recognize the satisfaction of all required conditions. These medicines may only be used by patients of traditional medicine clinics and may not be marketed as provided by the Pharmacy Law.

Article 27. Conditions for grant of operation licenses for medical assessment establishments

Medical assessment establishments that conduct medical examination and treatment shall apply one of the organizational forms specified in Articles 24 and 25 of this Circular.

Article 28. Conditions for grant of operation licenses for maternity homes

1. Physical foundations:

a/ Building and designing:

- A maternity home must be built firmly and have sufficient professional activity rooms which are well lit and have dustproof ceilings, and walls and floors made of easy-to-clean materials;

- Rooms of a maternity home must be interconnected and convenient for first-aid, medical examination and treatment.

b/ A maternity home must have rooms for pre-natal and gynecological checkup and family planning techniques, which are at least 10 m2 large each; a delivery room which is at least 16 m2 large; and a room for lying-in women which is at least 20 m2 large, to ensure at least 5 m2 for each bed;

c/ Rooms specified at Points a and b, Clause 1 of this Article must satisfy the requirements on work structure and designing specified at Point 5.4, Clause 5 of the Minister of Health’s Decision No. 2271/2002/QD-BYT of June 17, 2002, promulgating the design standard: Grassroots health stations - sector standard;

d/ A maternity home must treat its medical wastes and satisfy the radiation safety conditions (if any) under law;

e/ A maternity home must have sufficient electricity and water supply and satisfy other conditions for patient care.

2. Medical equipment:

a/ A maternity home must have sufficient medical equipment and instruments suitable to the scope of its registered professional activities;

b/ A maternity home must have vehicles for internal and external emergency transportation. A maternity home having no vehicles for internal and external emergency transportation shall sign contracts with establishments having such vehicles.

3. Organization and personnel:

a/ A maternity home must have an organizational apparatus suitable to the scope of its professional activities registered in the dossier of application for operation license;

b/ A person in charge of professional and technical activities of a maternity home must satisfy the following conditions:

- Being a doctor or bachelor in midwifery (university graduate) and having a practice certificate;

- Having conducted medical examination and treatment in gynecology and obstetrics for at least 54 months, for doctors, or at least 45 months, for midwifery bachelors (university graduates);

- Working on a full-time basis in the maternity home.

c/ Apart from the person in charge of professional and technical activities of a maternity home, other persons working in such maternity home and wishing to conduct medical examination and treatment must have a practice certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of these persons to conduct medical examination and treatment must be suitable to the scope of professional activities stated in their practice certificates.

4. Scope of professional activities:

a/ Pre-natal checkup and pregnancy management;

b/ Obstetrical first-aid;

c/ Tetanus vaccination;

d/ Urinary protein test;

e/ Midwifery;

f/ Manual removal (scaping) of post-natal or post-miscarriage retained placenta;

g/ Placement of intrauterine contraceptive devices;

h/ Internal vacuum extraction or abortion of fetuses up to 6 weeks old (between 36 and 42 days from the first day of the last menstruation), provided the conditions specified in the national standard for reproductive health care services promulgated by the Ministry of Health are satisfied;

i/ Other professional techniques as approved by provincial-level Health Department directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundations of each clinic.

Article 29. Conditions for grant of operation licenses for image diagnosis clinics

1. Physical foundation:

a/ Building and designing:

- An image diagnosis clinic must a fixed location separated from daily-life activities of surrounding households;

- An image diagnosis clinic must be built firmly and have dustproof ceiling and walls and floors made of easy-to-clean materials;

- X-ray, computed tomography (CT) scanner and magnetic resonance imaging (MRI) rooms must satisfy the radiation safety conditions specified by law;

- Ultrasonic and endoscopic diagnosis rooms must be independent and at least 10 m2 large each. Particularly for gastroendoscopy, if both upper and lower gastroendoscopic techniques are performed, there must be two separate rooms;

b/ An image diagnosis clinic must treat its medical wastes and satisfy the radiation safety conditions specified by law;

c/ An image diagnosis clinic must have sufficient electricity and water supply and satisfy other conditions for patient care.

2. Medical equipment:

a/ An image diagnosis clinic must have sufficient medical equipment and instruments suitable to its registered scope of professional activities;

b/ An image diagnosis clinic must have personal protection devices required by the law on radiation safety.

3. Personnel:

a/ A person in charge of professional and technical activities of an image diagnosis clinic must be a doctor having a practice certificate and having conducted medical examination and treatment in image diagnosis for at least 54 months;

b/ Apart from the person in charge of professional and technical activities of an image diagnosis clinic, other persons working in such clinic and wishing to conduct medical examination and treatment must have a practice certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of these persons to conduct medical examination and treatment must be suitable to the scope of professional activities stated in their practice certificates.

4. Scope of professional activities:

a/ X-ray-, computed tomography- and ultrasonic resonance imaging-based diagnosis;

b/ Doppler ultrasonic, common ultrasonic and endoscopic diagnosis;

c/ Image diagnosis clinics may not use intravenous contrast agents;

d/ Image diagnosis clinics may not perform ultrasonic-guided probing, endoscopic operation, bronchial tube scopy and hemorrhagic X-ray interventions;

e/ X-ray bachelors (university graduates) may not make diagnostic conclusions;

f/ Other professional techniques as approved by provincial-level Health Department directors based on the actual capacity of practitioners and conditions of medical equipment and physical foundation of clinics.

Article 30. Conditions for grant of operation licenses for testing laboratories

1. Physical foundation:

a/ Building and designing:

- A testing laboratory must be located separately from daily-life activities of surrounding households;

-  A testing laboratory must satisfy the requirements on architectural design and technical solutions specified in Sections 6 and 7 of the Minister of Health’s Decision No. 35/2005/QD-BYT of October 31, 2005, promulgating the design standard: testing departments of polyclinics - sector standard;

b/ In addition to the conditions specified at Point a, Clause 1 of this Article, a testing laboratory providing tests of microorganisms likely to cause infectious diseases in humans must satisfy the conditions specified in the Government’s Decree No. 92/2010/ND-CP of August 30, 2010, on assurance of bio-safety in laboratories;

c/ A testing laboratory must treat its medical wastes under law;

d/ A testing laboratory must have sufficient electricity and water supply and satisfy the conditions for patient care.

2. Medical equipment:

A testing laboratory must have sufficient testing devices and medical equipment for performing at least one of the six microbiological, biochemical, hematological, immunological, pathoanatomical and medico-genetic tests.

3. Personnel:

a/ A person in charge of professional and technical activities of a testing laboratory must satisfy the following conditions:

- Being a biological doctor or bachelor or a chemical bachelor or a university pharmacist or a testing technician (university graduate) and having a practice certificate;

- Having conducted medical tests for at least 54 months, including the period of postgraduate study in testing, from the date of starting to perform testing jobs (counting from the date of signing a labor contract or obtaining a recruitment decision)  to the date of being assigned or appointed to act as the person in charge of professional and technical activities of a testing laboratory.

b/ Apart from the person in charge of professional and technical activities of a testing laboratory, other persons working in such testing laboratory and wishing to conduct medical examination and treatment must have a practice certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of these persons to conduct medical examination and treatment must be suitable to the scope of professional activities stated in their practice certificates.

4. Scope of professional activities:

A testing laboratory may only perform tests suitable to its existing testing equipment and actual capacity of its practitioners.

Article 31. Conditions for grant of operation licenses for injection, dressing change, pulse counting, temperature and blood pressure measurement service establishments

1. Physical foundation:

a/ A service establishment must be built firmly in a fixed location, well lit and separated from daily-life activities of surrounding households;

b/ A room for injection or dressing change must be at least 10 m2 large;

c/ A service establishment must have sufficient electricity and water supply and satisfy other sanitation conditions for patient care.

2. Medical equipment:

a/ A service establishment must have sufficient medical equipment and instruments suitable to the scope of its registered professional activities;

b/  A service establishment must have an anti-shock medicine box.

3. Personnel:

a/ A person in charge of professional and technical activities of an injection, dressing change, pulse counting, temperature and blood pressure measurement service providing  must satisfy the following conditions:

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

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

b/ Apart from the person in charge of professional and technical activities specified at Point a of this Clause, other persons working in a service establishment and wishing to conduct medical examination and treatment must have a practice certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of these persons to conduct medical examination and treatment must be suitable to the scope of professional activities stated in their practice certificates.

4. Scope of professional activities:

a/ Injection and dressing change according to doctor prescriptions;

b/ Pulse counting and temperature and blood pressure measurement;

c/ Service establishments may not perform transfusion, medical examination and treatment and give prescriptions.

Article 32. Conditions for grant of operation licenses for denture prosthesis service establishments

1. Physical foundation:

a/ A dental and denture prosthesis room must be at least 10 m2 large;

b/ A denture prosthesis room must be at least 10 m2 large or is rent under a contract from another denture prosthesis establishment;

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

2. Medical equipment:

A denture prosthesis service establishment must have sufficient medical equipment and instruments suitable to the scope of its registered professional activities.

3. Personnel:

A person in charge of denture prosthesis must be a tooth implanter having practiced since 1980 or before at the age of full 18 or more and have a certificate thereof issued by the commune-level People’s Committee.

4. Scope of professional activities:

a/ Making of onlay and inlay denture prosthesis;

b/ Particularly, dental implanters in Ho Chi Minh City, who have been licensed for practice since 1980 or before and attended the municipal Health Department-organized professional training courses or passed a professional skill test (held in 1985 or 1986) and obtained a certificate of professional qualifications and wish to expand their scope of practice to filling teeth decayed at 1 or 2 level or extracting half-decayed teeth, must acquire additional relevant professional qualifications and have sufficient medical equipment and an anti-shock medicine box as required for these operations.

Article 33. Conditions for grant of operation licenses for home health care service establishments

1. Medical equipment:

A service establishment must have sufficient medical equipment and instruments suitable to the scope of its registered professional activities.

2. Personnel:

a/ A person in charge of professional and technical activities of a home health care service establishment must possess an intermediate or higher degree in medicine and a practice certificate and have conducted medical examination and treatment for at least 45 months;

b/ Apart from the person in charge of professional and technical activities of a home health care service establishment, other persons working in such establishment and wishing to conduct medical examination and treatment must have a practice certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of these persons to conduct medical examination and treatment must be suitable to the scope of professional activities stated in their practice certificates.

3. Scope of professional activities:

a/ Home health care services according to doctor prescriptions;

b/ Home health care service establishments may not perform transfusion, medical examination and treatment and give prescriptions.

Article 34. Conditions for grant of operation licenses for optical glasses service establishments

1. Physical foundation:

a/ An optical glasses service establishment must be built firmly in a fixed location, well lit and separated from daily-life activities of surrounding households;

b/ An optical glasses service establishment must be at least 15 m2 large;

c/ An optical glasses service establishment must have sufficient electricity and water supply and satisfy other sanitation conditions for patient care.

2. Medical equipment:

An optical glasses service establishment must have sufficient medical equipment and instruments suitable to the scope of its registered professional activities.

3. Personnel:

a/ A person in charge of professional and technical activities of an optical glasses service establishment must possess an intermediate or higher degree in medicine and a practice certificate and have conducted measurement, checking and diagnosis of refractive defects in an optical glasses service establishment or a medical examination and treatment establishment having an ophthalmological department for at least 45 months;

b/ An optical glasses service practitioner must have a practice certificate or  a certificate of expertise in medical equipment (equipment for measurement, checking and diagnosis of refractive defects) granted by a training establishment designated by the Ministry of Health.

4. Scope of professional activities:

a/ Measurement of refractive defects and counseling on use of optical glasses;

b/ Grinding and fitting of optical glasses according to doctor prescriptions and warranty for optical glasses.

Article 35. Conditions for grant of operation licenses for first-aid or patient transportation service establishments

1. Medical equipment and transportation vehicles:

a/ An establishment must have sufficient transportation vehicles, medical equipment and instruments, anti-shock medicine boxes and first-aid medicines for keeping patients safe;

b/ An establishment must have sufficient transportation vehicles ensuring environmental sanitation in the course of patient transportation.

2. Personnel:

a/ A person in charge of professional and technical activities of an establishment providing first-aid or patient transportation services at home or abroad must satisfy the following conditions:

- Being a doctor with a practice certificate;

- Having a certificate of study in the specialty of recuperation and first aid;

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

b/ Apart from the person in charge of professional and technical activities specified at Point a of this Clause, other persons working in an establishment providing first-aid or patient transportation services at home or abroad and wishing to conduct medical examination and treatment must have a practice certificate and may only conduct medical examination and treatment within the scope of their assigned jobs. The assignment of these persons to conduct medical examination and treatment must be suitable to the scope of professional activities stated in their practice certificates.

3. In case of registration for patient transportation abroad, a first-aid service and patient transportation establishment must have a contract signed with an aviation service company.

4. Scope of professional activities:

First-aid and transportation of patients at home and abroad.

Article 36. Conditions for grant of operation licenses for commune-level infirmaries and health stations

1. Physical foundation:

a/ A commune-level infirmary or health station must have a design under the Minister of Health’s Decision No. 2271/2002/QD-BYT of June 17, 2002, promulgating the design standard: Grassroots health station - sector standard.

b/ A commune-level infirmary or health station must satisfy the conditions of medical waste management and fire prevention and fighting under law;

c/ A commune-level infirmary or health station must have sufficient electricity and water supply and satisfy other conditions for patient care.

2. Medical equipment:

A commune-level infirmary or health station must have sufficient medical equipment and instruments suitable to the scope of its operational activities approved by the provincial-level Health Department director.

3. Organization and personnel:

The number of practitioners of a commune-level health station must satisfy the condition specified in Section IV of Joint Circular No. 08/2007/TTLT-BYT-BNV of June 5, 2007, of the Ministry of Health and the Ministry of Home Affairs, guiding non-business payrolls limits of state-owned health establishments.

4. Scope of professional activities:

a/ Commune-level infirmaries and health stations shall perform professional techniques on the list of techniques in medical examination and treatment promulgated by the Minister of Health, which are approved by provincial-level Health Department directors;

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

Article 37. Health establishments of agencies, units and organizations

1. Agencies, units and organizations that organize medical examination and treatment shall apply one of the organizational forms specified in Articles 24, 25 an 36 of this Circular.

2. For health establishments that conduct medical examination and treatment under the laws on drug, prostitution and HIV/AIDS prevention and control:

a/ In addition to the conditions specified by specialized laws, those commencing operation before January 1, 2012, must also satisfy the conditions specified in Article 25 of this Circular by January 1, 2016, at the latest;

b/ Those founded before January 1, 2012, must satisfy the conditions specified in Article 25 of this Circular in order to be granted operation licenses.

Section 2

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

Article 38. Competence to grant, re-grant or modify operation licenses for medical examination and treatment establishments

1. The Minister of Health and provincial-level Health Department directors may grant, re-grant or modify operation licenses for medical examination and treatment establishments under Clauses 1 and 2, Article 45 of the Law on Medical Examination and Treatment.

2. The Minister of Health may empower provincial-level Health Department directors to approve a number of matters related to operations of private hospitals and hospitals of other ministries and sectors already licensed by the Minister of Health and to report in writing these matters to the Ministry of Health right after approval, specifically as follows:

a/ To appraise and permit in writing changes in the number of patient beds and organizational structure (establishment of new departments or dissolution of existing departments or rooms), and to supplement the list of techniques under regulations;

b/ To permit in writing changes of hospital directors and persons in charge of professional and technical activities, department heads and other practitioners.

Article 39. Dossiers of application for grant, re-grant or modification of operation licenses for medical examination and treatment establishments

1. A dossier of application for grant, re-grant or modification of an operation license for a medical examination and treatment establishment specified in Clause 1, Article 46 of the Law on Medical Examination and Treatment comprises:

a/ An application for an operation license, made according to the form provided in Appendix 13 to this Circular;

b/ A certified copy of the establishment decision, for state-owned medical examination and treatment establishments, or of the business registration certificate, for private medical examination and treatment establishments, or of the investment certificate, for foreign-invested medical examination and treatment establishments;

c/ Certified copies of practice certificates of all practitioners and a list of registered practitioners of the medical examination and treatment establishment, made according to the form provided in Appendix 6 to this Circular;

d/ A declaration of physical foundation and medical equipment of the medical examination and treatment establishment, made according to the form provided in Appendix 14 to this Circular;

e/ Personnel files of medical workers in the establishment who are not required to acquire a practice certificate.

f/ Documents evidencing that the medical examination and treatment establishment satisfies the conditions of physical foundation, medical equipment, organization and personnel suitable to the scope of professional activities of its organizational form as specified in Section 1, Chapter III of this Circular;

g/ An organization and operation regulation, for state-owned hospitals, made according to the Minister of Health’s Decision No. 5571/QD-BYT of December 29, 2006, promulgating the model organization and operation regulation of hospitals attached to the Ministry of Health; or made according to the form provided in Appendix 15 to this Circular, for private hospitals, and an initial operation plan of the hospital;

h/ A certified copy of the contract with an aviation service company for transportation of patients, for establishments providing first-aid and patient transportation abroad;

i/ A certified copy of the patient transportation contract, for hospitals having no emergency transportation vehicles;

j/ Projected scope of professional activities: A medical examination and treatment establishment shall propose the scope of its professional activities and the list of techniques it plans to perform based on the list of professional techniques promulgated by the Minister of Health.

2. For a medical examination and treatment establishment upon organizational transformation, splitting up, division, consolidation or merger, a dossier of application for an operation license complies with Clause 1 of this Article.

3. For a medical examination and treatment establishment upon relocation, a dossier of application for an operation license complies with Points b, d, f, g and h, Clause 1 of this Article, together with an application made according to the form provided in Appendix 16 to this Circular.

4. For a medical examination and treatment establishment upon renaming, a dossier of application for an operation license complies with Points b, f, g and h, Clause 1 of this Article, together with an application made according to the form provided in Appendix 17 to this Circular.

5. For a medical examination and treatment establishment having its operation license lost, damaged or revoked, a dossier of application for re-grant of such operation license complies with Point a, Clause 1 of Article 48 of the Law on Medical Examination and Treatment, together with the damaged original license (if any) and an application made according to the form provided in Appendix 18 to this Circular.

6. For a medical examination and treatment establishment having a change in the number of patient beds or organizational structure or scope of professional activities, a dossier of application for modification of its operation license complies with Clause 3, Article 46 of the Law on Medical Examination and Treatment, together with a declaration of its physical foundation and medical equipment and personnel files suitable to the scale and scope of professional activities it plans to change, and an application made according to the form provided in Appendix 19 to this Circular.

Article 40. Procedures for grant, re-grant and modification of operation licenses

1. A dossier of application for grant, re-grant and modification of an operation license for a medical examination and treatment establishment specified in Article 39 shall be filed as follows:

a/ For medical examination and treatment establishments falling under the competence specified Clause 1, Article 45 of the Law on Medical Examination and Treatment, a dossier set shall be filed with the Medical Examination and Treatment Management Department of the Ministry of Health, except the cases specified in Clause 2, Article 38 of this Circular;

b/ For medical examination and treatment establishments falling under the competence specified Clause 2, Article 45 of the Law on Medical Examination and Treatment and the cases specified in Clause 2, Article 38 of this Circular, a dossier set shall be filed with the provincial-level Health Department.

2. Procedures for considering the grant, re-grant or modification of operation licenses:

a/ After receiving a dossier of application for grant, re-grant or modification of an operation license, the Ministry of Health or the provincial-level Health Department (below collectively referred to as the dossier-receiving agency) shall send to the applying medical examination and treatment establishment a dossier receipt, made according to the form provided in Appendix 20 to this Circular;

b/ Within the time limit specified at Point b or c, Clause 1, Article 47 of the Law on Medical Examination and Treatment, counting from the date indicated in the dossier receipt, if no supplementation is needed, the dossier-receiving agency shall consider and grant, re-grant or modify the operation license. If refusal to grant, re-grant or modify the license, it shall reply in writing, clearly stating the reason;

c/ In case a dossier of application for grant, re-grant or modification of an operation license is invalid, within 10 working days after the date indicated in the dossier receipt, the dossier-receiving agency shall notify such in writing to the applying medical examination and treatment establishment for completion of the dossier. A written notice must clearly state documents which must be added or contents which must be modified;

d/ Upon receiving a written notice requesting the completion of the dossier, the applying medical examination and treatment establishment shall make supplementations or modifications as required in the notice and send the supplemented or modified dossier to the dossier-receiving agency. The date of receipt of the supplemented or modified dossier shall be indicated in the dossier receipt. Within 10 working days after the date of receipt of the supplemented or modified dossier, if the dossier-receiving agency makes no written request for supplementation or modification, it shall grant, re-grant or modify the operation license within the time limit specified at Point b or c, Clause 1, Article 47 of the Law on Medical Examination and Treatment. In case of refusal to grant, re-grant or modify the operation license, it shall reply in writing, clearly stating the reason;

e/ In case the applying medical examination and treatment establishment has supplemented or modified its dossier but not up to requirements, the dossier-receiving agency shall request it to further supplement or modify its dossier under Points c and d, Clause 2 of this Article.

3. Operation licenses granted by the Minister of Health or provincial-level Health Department directors are made according to the form provided in Appendix 21 to this Circular.

Section 3

ORGANIZATION OF GRANT, RE-GRANT AND MODIFICATION OF OPERATION LICENSES FOR MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Article 41. Organization of appraisal for grant, re-grant or modification of operation licenses for medical examination and treatment establishments

1. The Minister of Health shall form a team for appraisal for grant, re-grant or modification of an operation license for a medical examination and treatment establishment attached to the Ministry, a private hospital or a hospital of another ministry or sector. Such a team is composed of:

a/ A representative of the leadership of the Medical Examination and Treatment Management Department as the team head;

b/ A representative of the leadership of the Legal Department as a team deputy head;

c/ A representative of the leadership of the Traditional Medicine and Pharmacy Department as a team deputy head (for appraisal of traditional medical examination and treatment establishments);

d/ A representative of the Medical Equipment and Work Department;

e/ A representative of the provincial-level Health Department managing the medical examination and treatment establishment in the locality;

f/ A representative medical expert of another hospital having departments similar to the scope of professional activities that the applying medical examination and treatment establishment registers;

g/ Other related persons (representatives of medical management agencies of ministries or sectors, when necessary, for medical examination and treatment establishments of other ministries or sectors);

h/ An expert of the Medical Examination and Treatment Management Department or an expert of the Traditional Medicine or Pharmacy Department (for appraisal of traditional medical examination and treatment establishments) as the team secretary.

2. The director of a provincial-level Health Department shall form a team for appraisal for grant or modification of an operation license for a medical examination and treatment establishment other than that specified in Clause 1 of this Article. Such a team is composed of:

a/ A representative of the leadership of the provincial-level Health Department or a representative of the standing unit of the appraisal team as specified in Clause 3 of this Article, as the team head;

b/ A representative of the leadership of the practice management section or the medical professional operation section (for provincial-level Health Departments without the practice management section) as a team deputy head;

c/ A representative of the medical professional operation section (for provincial-level Health Departments with the practice management section) as a team deputy head;

d/ A representative of the organization and personnel section (for appraisal of state-owned medical examination and treatment establishments);

e/ A representative of another hospital having departments similar to the scope of professional activities that the applying medical examination and treatment establishment registers (when necessary);

f/ Other related persons, when necessary (representatives of medical management agencies of ministries or sectors, for medical examination and treatment establishments of other ministries or sectors);

g/ An expert of the practice management section or the medical professional operation section (for provincial-level Health Departments without the practice management section) as the team secretary.

3. The standing unit of an appraisal team specified in Clause 1 of this Article shall be based at the Medical Examination and Treatment Management Department of the Ministry of Health. The standing unit of an appraisal team specified in Clause 2 of this Article shall be based at the practice management section or the medical professional operation section (for provincial-level Health Departments without the practice management section) of the provincial-level Health Department.

Article 42. Procedures for appraisal for grant, re-grant or modification of operation licenses for medical examination and treatment establishments

1. Procedures for appraisal for grant or modification of an operation license of a medical examination and treatment establishment include:

a/ Examination of the legal dossier; inspection of conditions of the physical foundation, medical equipment and instruments, organization and personnel of the medical examination and treatment establishment; appraisal of the scope of professional activities;

b/ Making of a written record of appraisal according to the form provided in Appendix 22 to this Circular;

c/ A written record of appraisal of a medical examination and treatment establishment under the management of the Minister of Health shall be made in three copies: One to be kept at the Ministry of Health, one to be kept at the provincial-level Health Department of the locality in which the medical examination and treatment establishment is located, and another to be kept at the appraised medical examination and treatment establishment.

2. Procedures for appraisal for re-grant of an operation license of a medical examination and treatment establishment include:

a/ Examination of the dossier subject to previous appraisal for grant of the operation license which is kept at the Ministry of Health or the provincial-level Health Department or the damaged operation license (if any);

b/ Re-grant of the operation license according to the form provided in Appendix 21 to this Circular.

3. Management of operation licenses:

a/ Each medical examination and treatment establishment may be granted only one operation license;

b/ Copies of operation licenses and dossiers of application for grant or re-grant of operation licenses shall be kept at licensing agencies;

c/ After granting an operation license to a medical examination and treatment establishment:

- Within 30 days after the date of grant, re-grant, modification or revocation of the operation license, the Ministry of Health shall notify it in writing to the provincial-level People’s Committee and Health Department of the locality in which the licensed medical examination and treatment establishment is located;

- Within 30 days after the date of grant, re-grant, modification or revocation of the operation license, a provincial-level Health Department shall notify it in writing to the People’s Committee of the district, town or provincial city in which the licensed medical examination and treatment establishment is located.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 43. Effect

This Circular takes effect on January 1, 2012.

To annul the Ministry of Health’s Circular No. 07/2007/TT-BYT of May 25, 2007, guiding medical practice, traditional medicine and medical equipment in the private health sector.

Article 44. Reference provisions

In case documents mentioned in this Circular are replaced or revised, replacing or revising documents will prevail.

Article 45. Organization of implementation

1. Responsibilities of the Ministry of Health:

a/ The Medical Examination and Treatment Management Department shall:

- Direct, guide, examine and inspect the implementation of this Circular nationwide;

- Build a data management system for the grant, re-grant and revocation of practice certificates, suspension of professional activities and practice of holders of practice certificates nationwide; grant, re-grant, modification or revocation of operation licenses nationwide; and practice registration.

- Publicly publish data related to the grant, re-grant and revocation of practice certificates and suspension of professional activities on the e-portal of the Ministry of Health or its website.

- Coordinate with the Planning and Finance Department and related units in elaborating plans on investment in and upgrading of infrastructure facilities, medical equipment and personnel of state-owned medical examination and treatment establishments under its management to satisfy the conditions specified in this Circular;

b/ The Planning and Finance Department shall assume the prime responsibility for, and coordinate with the Medical Examination and Treatment Management Department and related units in, elaborating plans on investment in and upgrading of infrastructure facilities, medical equipment and personnel of state-owned medical examination and treatment establishments under their management to satisfy the conditions specified in this Circular.

2. Ministries and sectors having medical examination and treatment establishments that are operating before the effective date of this Circular shall elaborate plans on investment in and upgrading of infrastructure facilities, medical equipment and personnel of state-owned medical examination and treatment establishments under their management to satisfy the conditions specified in this Circular.

3. Provincial-level People’s Committees shall invest in upgrading infrastructure, medical equipment and personnel of state-owned medical examination and treatment establishments under their management to satisfy the conditions specified in this Circular at the request of provincial-level Health Departments.

4. Responsibilities of provincial-level Health Departments:

a/ To elaborate plans on investment in and upgrading of infrastructure facilities, medical equipment and personnel of state-owned medical examination and treatment establishments under their management to satisfy the conditions specified in this Circular;

b/ Direct, guide, examine and inspect the implementation of this Circular in their respective localities;

c/ Revoke certificates of dental implanters which are granted before the effective date of this Circular in contravention of the Minister of Health’s Circular No. 07/2007/TT-BYT of May 25, 2007, guiding medical practice, traditional medicine and medical equipment in the private health sector.

d/ Make and post on their websites statistics on lists of:

- Practitioners whose practice certificates are granted, re-granted, modified or revoked or professional activities suspended in their localities;

- Practitioners who have registered for practice in their localities;

- Medical examination and treatment establishments to which operation licenses are granted, or which have their operation licenses re-granted, modified or revoked or are suspended from operation in their localities.

e/ Report on data on practitioners and medical examination and treatment establishments specified at Point d, Clause 2 of this Article to the Ministry of Health (the Medical Examination and Treatment Management Department) once every six months. Particularly, lists of practitioners registered for practice shall be reported under Clause 2, Article 14 of this Circular.

5. Medical examination and treatment establishments that are operating before January 1, 2012, shall elaborate plans on investment in and upgrading of their infrastructure facilities, medical equipment and personnel to satisfy the conditions specified in this Circular.

Article 46. Implementation responsibility

1. The director of the Medical Examination and Treatment Management Department, the director of the Traditional Medicine and Pharmacy Department, the director of the Legal Department and the Inspectorate of the Ministry of Health shall, within the ambit of their assigned functions and tasks and vested powers, coordinate with related departments, directorates and administrations in examining and inspecting the grant of practice certificates and operation licenses to and the medical examination and treatment and the observance of law by medical examination and treatment establishments nationwide.

2. Provincial-level Health Department directors shall examine and inspect the grant of practice certificates and operation licenses to and the medical examination and treatment and the observance of law by medical examination and treatment establishments in their respective localities.

Any problems arising in the course of implementation should be promptly reported to the Ministry of Health (the Medical Examination and Treatment Management Department) for study and settlement.-

For the Minister of Health
Deputy Minister
NGUYEN THI XUYEN

* Note: All appendices to this Circular are not printed herein.