Circular No. 24/2011/TT-BYT dated June 21, 2011 of the Ministry of Finance guiding the import of medical devices

THE MINISTRY OF HEALTH

Circular No. 24/2011/TT-BYT of June 21, 2011, guiding the import of medical devices

Pursuant to the June 14, 2005 Commercial Law;

Pursuant to the November 21, 2007 Law on Product and Goods Quality;

Pursuant to Decree No. 12/2006/ND-CP of January 23, 2006, detailing the Commercial Law regarding international goods trading and goods purchase and sale agency, processing and transit with foreign countries;

Pursuant to Decree No. 89/2006/ND-CP of August 30, 2006, on goods labeling;

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

Pursuant to the Prime Minister’s Decision No. 10/2010/QD-TTg of February 10, 2010, on certificates of free sale for imported and exported products and goods;

The Ministry of Health guides the import of medical devices as follows:

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular guides the import of brandnew medical devices by Vietnamese traders and related organizations and individuals (below referred to as importers) for sale in Vietnam.

Article 2. Interpretation of terms

Medical devices include devices, instruments, supplies and chemicals, including necessary software, for separate or combined use to serve humans for the following purposes:

a/ Preventing, examining, diagnosing, treating or lessening diseases or treating injuries;

b/ Examining, replacing, modifying or supporting surgeries during medical examination and treatment;

c/ Supporting or maintaining life;

d/ Controlling conception;

e/ Medical sterilization (excluding insecticidal or germicidal chemicals and preparations for household and medical use);

f/ Specialized transportation to serve health activities.

Chapter II

CONDITIONS, COMPETENCE AND PROCEDURES FOR GRANTING MEDICAL DEVICE IMPORT LICENSES

Article 3. Conditions on medical device importers

1. Legal conditions:

Having a business registration certificate or investment certificate for the trading and import of medical devices.

2. Personnel conditions:

a/ Officers in charge of technical matters must meet one of the following requirements:

Possessing a university degree in biomedical electronics, biomedical physics, or a university diploma in a technical discipline, medicine or pharmacy and a certificate of training in medical devices awarded by a lawful medical equipment technique training institution or an equivalent certificate of training in a field relevant to medical devices to be imported, awarded by a foreign institution.

For officers who possess a university degree in a technical discipline or in medicine or pharmacy and have personally worked with medical device techniques or managed medical devices at a lawful medical establishment for three or more years, for which they have a written certification issued by the head of their employing unit, they are not required to have a certificate of training in medical devices.

b/ Having technical staff capable of guiding the installation, warranty and maintenance of medical devices to be imported.

3. Physical foundation conditions:

a/ Having facilities and storehouses for proper preservation of medical devices in appropriate conditions avoiding the impacts of light, temperature and humidity and other conditions;

b/ Having fire and explosion prevention and fighting equipment and ensure environmental sanitation as provided by law.

4. Labels of imported medical devices:

To comply with the Government’s Decree No. 89/2006/ND-CP of August 30, 2006, on goods labeling, the Ministry of Science and Technology’s Circular No. 09/2007/TT-BKHCN of April 6, 2007, guiding a number of articles of Government’s Decree No. 89/2006/ND-CP, and other relevant regulations.

Article 4. Medical devices licensed for import

1. Importers shall apply for import licenses at the Ministry of Health when wishing to import medical devices on the list in Appendix 1 to this Circular.

2. For medical devices outside the list in Appendix 1 to this Circular, import licenses are required if they are to be used for implementing new methods of diagnosis and treatment and imported for the first time into Vietnam.

3. Importers do not need import licenses for medical devices not on the list in Appendix I, except cases stated in Clause 2, Article 4 of this Circular, but shall satisfy the requirements specified at Points b and c, Clause 1, Article 5 of this Circular.

Article 5. Dossiers and procedures of application for medical device import licenses

1. A dossier of application for a medical device import license (1 set) comprises:

a/ An application for import license, signed and stamped by the head of the importer or a lawfully authorized person, made according to the form provided in Appendix 2 to this Circular (not printed herein);

b/ The legal dossier:

Business registration certificate or investment certificate (notarized copy).

c/ Dossier of medical devices to be imported:

- Valid certificate of satisfaction of international quality management standard ISO 13485 or ISO 9001, duly issued by the manufacturer or country of manufacture.

- Valid certificate of free sale for imported medical devices in the country of manufacture, or certificate of free sale of FDA, the US, or European CE mark certificate (original or copy certified in Vietnam or consularly legalized by the Vietnamese diplomatic representative mission or embassy in the country of manufacture). Requirements on minimum information in certificates of free sale of imported medical devices are provided in Appendix 3 to this Circular (not printed herein).

- Valid paper of authorization by the manufacturer of lawful distributor to the importer to import or distribute medical devices in Vietnam (original or copy certified in Vietnam or consularly legalized by the Vietnamese diplomatic representative mission or embassy in the country of manufacture).

- Catalogs of medical devices to be imported (original or copy certified by the importer).

- Vietnamese-language technical documents describing medical devices to be imported, made according to Appendix 4 to this Circular (not printed herein).

2. Documents in a dossier of application for a medical device import license must be arranged in the order stated in Appendix 5 to this Circular (not printed herein) and bound into a volume for each type of medical device with its front-cover page showing the name of the importer and contact information and address. For a type of medical device imported from different manufacturers or countries of manufacture, products of each manufacturer or country of manufacture must have sufficient documents arranged in the required order and stated in the importer’s application for an import license.

3. Procedures of application for medical device import licenses:

a/ For first-time importation: The importer shall make a dossier of application as guided in Clauses 1 and 2, Article 5 of this Circular, and send it to the Ministry of Health (the Medical Devices and Works Department) at No. 138A, Giang Vo, Ba Dinh, Hanoi.

- For medical devices outside the list in Appendix 1 to this Circular but to be used for implementing new methods of diagnosis and treatment and imported for the first time into Vietnam: In addition to the conditions and dossier of application as specified Clause 1, Article 5, these medical devices must have results of clinical trial test results and be appraised and permitted by the Ministry of Health’s Science and Technology Council for their import.

For some special medical devices already accepted and recommended by international organizations for use in different countries, the Ministry of Health shall consider exempting them from clinical trial test on the basis of conclusions of its Science and Technology Council.

b/ For importation from the second time on (from the effective date of this Circular):

- The importer is not required to submit its legal dossier as stated at Point b, Clause 1, Article 5 of this Circular.

- If importing medical devices of the same category, manufacturer or country of manufacture as previously licensed by the Ministry of Health, the importer is not required to submit the catalogs of and technical documents describing medical products to be imported as stated at Point c, Clause 1, Article 5 of this Circular.

- The importer shall submit a copy of the previous import license.

Article 6. Grant of medical device import licenses

1. The Ministry of Health shall consider and grant import licenses for medical equipment in Appendix 1 within 15 working days after receiving complete and valid dossiers. In case of refusal to grant licenses, the Ministry of Health (the Medical Devices and Works Department) shall issue written replies clearly stating the reasons to importers.

2. The validity duration of an import license is 1 (one) year from the date of its signing.

3. The import licensing fee: The importer that is granted an import license shall pay an import fee under current regulations and the Ministry of Finance’s Decision No. 44/2005/QD-BTC of July 12, 2005, and Decision No. 59/2008/QD-BTC of July 21, 2008, prescribing the collection, remittance, management and use of charges for appraisal of conditional businesses in the health sector, charges for appraisal of standards and conditions for practicing medicine or pharmacy, and fees for the grant of import and export licenses and certificates of practice of medicine or pharmacy.

Chapter III

HANDLING OF VIOLATIONS

Article 7. Handling of violations

1. When detecting an importer that forges or arbitrarily modifies legal dossiers, documents and papers of competent Vietnamese or foreign authorities; uses a forged stamp or imitates the signature or stamp of an importer or a related agency in the dossier of import of medical devices, the Ministry of Health (the Medical Devices and Works Department) shall issue a written caution to it and stop receiving and considering its import dossier, specifically as follows:

a/ Stopping receiving and considering the importer’s dossier of import of medical devices for 3 months, for first-time violations;

b/ Stopping receiving and considering the importer’s dossier of import of medical devices for between 6 and 12 months, for second-time violations committed within a 12-month period;

c/ Depending on the seriousness of the violation, the Ministry of Health (the Medical Devices and Works Department) shall issue an official letter notifying the violation to the importer and stop receiving and considering the importer’s dossier of import of medical devices.

In addition to the above forms, the Ministry of Health (the Medical Devices and Works Department) shall post the details of the importer’s violation on the Ministry’s website and notify it to the inspection agencies, customs offices and competent functional agencies for consideration and handling in accordance with law.

2. Violators shall, depending on the seriousness of their violations, be administratively disciplined or sanctioned or examined for penal liability; if causing damage, they shall pay compensations in accordance with law.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 8. Implementation responsibilities

1. The Medical Devices and Works Department is a standing unit of the Ministry of Health for summing up and submitting import dossiers to the Advisory Council for Medical Device Import Licensing, the Ministry of Health, for appraisal.

2. The Ministry of Health’s Inspectorate shall coordinate with functional departments and administrations of the Ministry of Health in examining and inspecting the trading and importation of medical devices nationwide.

3. Provincial-level Health Departments shall examine and inspect the trading and importation of medical devices in their respective localities.

4. Importers shall strictly implement the law and take responsibility for categories, quantities and quality of imported medical devices and notify, recall and issue warnings about unsafe products harmful to users and the community.

5. Importers shall annually send reports (before January 30) on the import of medical devices (names, quantities, categories, manufacturers, countries of manufacture, users and import values of devices) to the Ministry of Health (the Medical Devices and Works Department) according to the provisions in Appendix 6 to this Circular (not printed herein).

After the annual reporting deadline, the Advisory Council for Medical Device Import Licensing, the Ministry of Health, shall base itself on importers’ reports to consider and appraise dossiers and grant medical device import licenses to the importers for subsequent times.

Importers shall report in writing any changes in their names and transaction addresses, leadership, officers in charge of technical matters, importation, etc. to the Ministry of Health (the Medical Devices and Works Department) after making such changes.

Article 9. Effect

This Circular takes effect on August 15, 2011.

To annul the provisions on the import of medical devices of the Ministry of Health’s Circular No. 08/2006/TT-BYT of June 13, 2006, guiding the import of vaccines, medical biologicals, insecticidal and germicidal chemicals and preparations for household and medical use, and medical devices, and Circular No. 09/2006/TT-BYT of July 11, 2006, guiding amendments and supplements to Section IV and Appendix 9 to Circular No. 08/2006/TT-BYT.

Any problems arising in the course of implementation should be promptly reported to the Ministry of Health (the Medical Devices and Works Department) for consideration and settlement.-

For the Minister of Health
Deputy Minister
NGUYEN THI KIM TIEN

Appendix 1

List of brandnew medical devices allowed to be imported under licenses of the Ministry of Health

(To the Ministry of Health’s Circular No. 24/2011/TT-BYT of June 21, 2011)

Note: Annually, the Ministry of Health (the Medical Devices and Works Department) shall consider, modify and update the list in Appendix 1 to create favorable conditions for importers and suit the practical work of management of the import and export of medical devices.-