Decision No. 36/2006/QD-BYT of the Ministry of Health promulgates regulations on clinical testing of medical devices, to take effect fifteen days after publication in the Official Gazette. These regulations govern the clinical testing activities of domestic and imported medical devices.
Scope of application
Organizations and individuals conducting clinical testing of medical devices, including both domestic and foreign entities.
Key points
- Clinical testing of medical devices is detailed in this Decision.
- Organizations and individuals must comply with safety regulations when conducting clinical testing activities.
- This Decision takes effect fifteen days after its publication in the Official Gazette.
- The duration and procedures for clinical testing are specified in detail in this Decision.
- Organizations and individuals are responsible for the safety of medical devices during clinical testing activities.
🌐 Social impact of this document
- Positive impact: Ensuring the safety and effectiveness of medical devices before widespread use.
- Negative impact: May incur time and cost expenses for organizations conducting clinical testing.
❓ Frequently asked questions
Who does this Decision apply to?
This Decision applies to organizations and individuals conducting clinical testing of domestic and imported medical devices.
What is the effective period of this Decision?
This Decision takes effect fifteen days after its publication in the Official Gazette.
What regulations must organizations and individuals comply with when conducting clinical testing of medical devices?
Organizations and individuals must ensure safety during the clinical testing process and follow specific regulations outlined in this Decision.
Does this Decision come into effect immediately upon issuance?
No, this Decision takes effect fifteen days after its publication in the Official Gazette.
Which organizations and individuals are responsible for implementing this Decision?
The Director of the Office, the Inspector General, Heads of Departments under the Ministry of Health, the Director of the Drug Administration of Vietnam, the Director of the Food Safety and Control Department, the Director of the Preventive Medicine Department, the Director of the HIV/AIDS Prevention and Control Department, Directors of Provincial Health Services, Heads of Health Departments in centrally governed cities, and Heads of units directly under the Ministry of Health are responsible for implementing this Decision.
Full text
Pursuant to …;
Regarding the issuance of "Regulations on Clinical Trials of Medical Devices"
________________________
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 Decree No. 12/2006/NĐ-CP dated January 23, 2006 of the Prime Minister detailing the implementation of the Law on Trade regarding international trade activities and agency buying, selling, processing, and transiting goods with foreign countries;
At the proposal of the Heads of the Department of Science and Training, the Department of Medical Equipment and Health Facilities, and the Department of Legal Affairs.
Pursuant to …;
Article 1The "Regulations on Clinical Trials of Medical Devices" are hereby promulgated together with this Decision.
Article 2This Decision shall take effect fifteen days from the date of publication in the Official Gazette.
Article 3The Heads of the Office, Inspectorate, Departments under the Ministry of Health, Director of the Vietnam National Pharmaceutical Administration, Director of the Food Safety and Control Department, Director of the Preventive Medicine Department, Director of the HIV/AIDS Prevention and Control Department, Directors of Provincial and Municipal Health Services, Heads of Health Services of sectors, and Heads of units directly under the Ministry of Health are responsible for implementing this Decision./.
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