VietnameseCircular No. 39/2016/TT-BYT dated October 28, 2016 of the Ministry of Health on classification of medical devices
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ATTRIBUTE
| Issuing body: | Ministry of Health | Effective date: | Known Please log in to a subscriber account to use this function. Don’t have an account? Register here |
| Official number: | 39/2016/TT-BYT | Signer: | Nguyen Viet Tien |
| Type: | Circular | Expiry date: | Known Please log in to a subscriber account to use this function. Don’t have an account? Register here |
| Issuing date: | 28/10/2016 | Effect status: | Known Please log in to a subscriber account to use this function. Don’t have an account? Register here |
| Fields: | Health |
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THE MINISTRY OF HEALTH
Circular No. 39/2016/TT-BYT dated October 28, 2016 of the Ministry of Health on classification of medical devices
Pursuant to the Government s Decree No. 63/2012/ND-CP dated August 31, 2012 defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to Clause 5 Article 5 of the Government s Decree No. 36/2016/ND-CP dated May 15, 2016 on management of medical devices;
At the request of Director of Health Device and Work Department,
The Minister of Health promulgated a Circular on classification of medical devices.
Article 1. Classification of medical devices
1. Medical devices are classified into 4 classes (A, B, C, D) according to the rules specified in Appendix I enclosed herewith.
2. Medical devices are classified into 4 classes (A, B, C, D) according to the grouping principles specified in Appendix II enclosed herewith.
Article 2. Effect and responsibility for implementation
1. This Circular takes effect on December 15, 2016.
2. Organizations qualified for classification of medical devices shall apply the rules mentioned in Article 1 of this Circular.
Any difficulties arising in the course of implementation of this Circular should be reported to the Ministry of Health for consideration./.
For the Minister
The Deputy Minister
Nguyen Viet Tien
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