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Vinacontrol recognized medical device classification capacity
Table Of Contents
Table Of Contents
On 29 May, the Department of Medical Equipment and Works received the "Medical Device Classification Profile" of Vinacontrol Hanoi, a branch of Vinacontrol Corporation. Classification of equipment is in the procedure/stage prescribed by the law on management of medical equipment in production and trading.
The requirements for classification of medical equipment are specified in Decree 36/2016 / ND-CP on management of medical equipment. Accordingly, the medical equipment consists of four categories divided into two groups based on the level of potential risks related to technical design and production of medical equipment that:
- Group 1 includes medical equipment of type A which is medical equipment with low risk level.
- Group 2 includes medical equipment of types B, C and D, of which:
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- Medical equipment of category B is low average risk level medical equipment;
- Medical equipment of category C is medical equipment with high average risk level;
- Medical equipment of category D is a high-risk medical equipment.
Details published see here
Accreditation decision see here
