Decision No. 16/2005/QD-BYT on Issuing Seven Industry Standards for Medical Devices

This Decision issues seven industry standards for medical devices to ensure the quality and safety of medical products, applicable to production facilities, importers, and users of medical devices throughout the country.

Document No.16/2005/QĐ-BYT
Document typeDecision
Issuing authorityMinistry of Health
Signed byLê Ngọc Trọng — Thứ trưởng
Updated18/06/2026
SectorHealth
Issued date30/06/2005
Effective date15/07/2005
Expiry date
StatusIn effect
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This Decision issues seven industry standards for medical devices to ensure the quality and safety of medical products, applicable to production facilities, importers, and users of medical devices throughout the country.

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MINISTRY OF HEALTH

SOCIALIST REPUBLIC OF VIET NAM
Independence – Freedom – Happiness

Number: 16/2005/QĐ-BYT
Hanoi, June 30, 2005

Pursuant to …;

REGARDING THE ISSUANCE OF SEVEN INDUSTRY STANDARDS FOR MEDICAL EQUIPMENT

THE MINISTER OF HEALTH

- Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

- Pursuant to the Quality of Goods Ordinance dated December 24, 1999;

- Based on the proposal of the Heads of the Science and Training Department and the Medical Equipment and Infrastructure Department;

Pursuant to …;

Article 1. Attached to this Decision are seven industry standards for medical equipment (with an accompanying list).

Article 2. This Decision shall take effect fifteen days from the date of publication in the Official Gazette. All previous regulations that conflict with these standards are hereby abolished.

Article 3. The Heads of the Office, Heads of the Departments of Science and Training, Medical Equipment and Infrastructure, Planning and Finance, Treatment, and other relevant departments of the Ministry of Health; Directors of Provincial and Municipal Health Services directly under the Central Government are responsible for implementing this Decision./.

DEPUTY MINISTER
DEPUTY MINISTER
Le Ngoc Trong
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