THE MINISTRY OF PUBLIC HEALTH
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SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
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No: 07/2002/TT-BYT
Hanoi, May 30, 2002
 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.

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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.
 

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