Class II medical device filing

Legal analysis: 1, telephone consultation or on-site consultation, preparation of application materials;

2, online declaration, submission of paper information;

3, the staff online acceptance;

4, there is a warehouse staff on-site survey;

5, to receive the second class of medical equipment business For the record.

Legal basis: "Medical Device Business License Management Measures" Article 3 of the operation of the second and third class of medical devices should hold a "Medical Device Business License", but in the circulation of the process through the routine management of a small number of second class of medical devices can ensure its safety, effectiveness can not apply for a "Medical Device Business License". License". Do not need to apply for a "medical device business license" of the second class of medical devices by the State Food and Drug Administration to develop a product list.

Warm tips

The above answer, only the current information combined with my understanding of the law to make, please be careful to reference!

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