Circular No. 07/2002/TT-BYT dated May 30, 2003 of the Ministry of Health guiding the registration for circulation of medical equipment and facilities

CIRCULAR

GUIDING THE REGISTRATION FOR CIRCULATION OF MEDICAL EQUIPMENT AND FACILITIES

Pursuant to the July 11, 1989 Law on Protection of People’s Health;

Pursuant to the Government’s Decree No. 86/CP of December 8, 1995 prescribing the assignment of State management responsibilities for goods quality;

Pursuant to Joint-Circular No. 07/TTLB of July 1, 1996 of the Ministry of Health and the Ministry of Science, Technology and Environment guiding the implementation of Decree No. 86/CP;

Pursuant to the December 24, 1999 Ordinance on Goods Quality;

Pursuant to Decision No. 2424/2000/QD-BKHCNMT and Decision No. 2425/2000/QD-BKHCNMT of December 12, 2000 of the Minister of Science, Technology and Environment promulgating the Provisional Regulation on the announcement of goods compatibility with standards and the Provisional Regulation on the announcement of goods quality standards;

The Ministry of Health hereby guides the registration for circulation of medical equipment and facilities as follows:

I. GENERAL PROVISIONS

1.1. Medical equipment and facilities made in Vietnam must be granted the circulation registration numbers by the Ministry of Health before being circulated on the market.

1.2. This Circular prescribes the dossiers, procedures and competence to grant circulation registration numbers to home-made medical equipment and facilities.

1.3. For imported medical equipment and facilities, the provisions in the Prime Minister’s Decision No. 46/2001/QD-TTg of April 4, 2001 and legal documents guiding the implementation thereof shall apply.

II. PROVISIONS ON DOSSIERS OF REGISTRATION FOR CIRCULATION OF MEDICAL EQUIPMENT AND FACILITIES

The dossier of registration for product circulation must be made in a set, bound in hard cover, and have its contents arranged in the following order:

2.1. The application for circulation registration of medical equipment and facilities.

2.2. The business registration certificate (notarized copy), which inscribes the function of producing medical equipment and facilities.

2.3. The announcement of goods quality standards or the announcement of goods compatibility with standards.

2.4. The results of tests conducted in at least 03 Vietnamese medical establishments (depending on each type of product, the Ministry of Health shall designate medical establishments to conduct the tests).

2.5. The results of testing on chemical and physical properties as well as the results of safety expertise by functional bodies (for types of products requiring testing and/or expertise).

2.6. Technical documents and use instructions.

2.7. The products labels: In strict accordance with the Regulation on the labeling of goods to be circulated in the country as well as export and import goods, issued together with the Prime Minister’s Decision No. 178/1999/QD-TTg of August 30, 1999 and Circular No. 34/1999/TT-BTM of December 15, 1999 of the Ministry of Trade guiding the implementation thereof.

III. COMPETENCE AND PROCEDURES TO GRANT CIRCULATION REGISTRATION NUMBERS TO MEDICAL EQUIPMENT AND FACILITIES

3.1. The dossiers of registration for circulation of medical equipment and facilities shall be sent to the Ministry of Health (the Department of Medical Equipment-Facility and Project).

3.2. The Ministry of Health shall consider and grant circulation registration numbers to medical equipment and facilities within 15 days (working days) as from the date of receiving complete dossiers as prescribed; in case of refusal, it shall reply in writing, clearly stating the reasons therefor.

3.3. The circulation registration numbers shall be valid for three years as from the issuance date. Thirty days before the expiry date, if the units continue trading in and/or producing products which have already been granted circulation registration numbers, they shall have to carry out procedures for extension. During the permitted circulation period, if the producers make any changes in the products models or technical properties, they shall have to send written reports thereon to the Ministry of Health.

3.4. Units applying for the registration of medical equipment and facilities shall have to pay fees for registration of medical equipment and facilities according to current regulations.

IV. INSPECTION, EXAMINATION AND HANDLING OF VIOLATIONS

4.1. Organizations and individuals engaged in the production of and/or trading in medial equipment and facilities shall have to bear responsibility for their goods quality and be subject to the inspection and examination by the Ministry of Health and the provincial/municipal Health Services.

4.2. The Ministry of Health shall issue decisions to withdraw circulation registration numbers in the following cases: The medical equipment and facilities, which have been granted circulation registration numbers, but, during the use process, fail to meet the quality requirements or to comply with the registered dossiers, or untruthful information and advertisements are made or other mendacious acts are committed regarding goods quality.

4.3. Organizations and individuals that violate the provisions of this Circular and other relevant law provisions shall, depending on the nature and seriousness of their violations, be administratively sanctioned or examined for penal liability; if causing damage, they shall have to make compensation therefor according to law provisions.

V. IMPLEMENTATION PROVISIONS

5.1. This Circular takes effect 15 days after its signing for promulgation. All previous regulations contrary to this Circular are hereby annulled.

5.2. The Department of Medical Equipment-Facility and Project, the Health Ministry’s Inspectorate, the provincial/municipal Health Services, and organizations and individuals engaged in the production of and/or trading in medical equipment and facilities shall have to implement this Circular.