Songjiang handles medical device registration.

There are three types of business licenses for medical enterprises, of which the first type of medical device license can be directly handled, and the second type of medical device business registration certificate is required to operate the second type of products, so what I mainly tell you below is the requirements for the third type of medical device business license, and medical device enterprises should be prepared.

Records of Class II medical devices:

1, copy of graduation certificate of legal representative+copy of front and back of ID card.

2. Copy of the graduation certificate of the person in charge of the enterprise+copy of the front and back of the ID card.

3. A copy of the quality inspector's diploma+a copy of the front and back of the ID card.

4. Lease contract+site use certificate or filing certificate or real estate license.

5. License+official seal

6, floor plan

Remarks:

1, the legal representative with technical secondary school education or above may concurrently be the person in charge of the enterprise.

2. The person in charge of quality can't hold the post concurrently, with a college degree or above.

Medical device license processing flow

1, accept the application (2 working days) and issue an acceptance notice.

2, review and decide (5 working days), issued a "medical device business license" or "decision not to grant administrative license".

3. Certification and delivery (5 working days)