Medical device registration, refers to in accordance with the legal procedures, to be marketed for sale, the use of medical devices, the safety and effectiveness of the systematic evaluation, in order to decide whether to agree with its sales, use of the process. It is divided into the territory of the medical device registration and overseas medical device registration, overseas medical devices, whether it is a class, class II, class III to the State Food and Drug Administration in Beijing for: the territory of the first and second class medical devices in the local provincial or municipal food and drug supervision bureau for, class III to the State Food and Drug Administration for. The medical device registration certificate is the legal identity card of the medical machinery products.
AuZhida medical equipment consulting organization