Application for a class of medical devices for the record need to submit what information?

The first class medical device manufacturers to normal production and operation, you need to apply for the following documents:

A. First class medical device product registration filing;

0. A copy of the business license of the enterprise, a copy of the organization code certificate;

1. Product risk analysis information-safety risk analysis report

2. Product technical requirements<

3. Product compliance with the list of national industry standards

4. Product test report Jining

5. Clinical evaluation information ball request

6. Product instructions and labels 154

8 production and manufacturing information 963

9 Clinical evaluation information 2616

Two, the first class of medical devices production record;

1 Business license, copy of organization code

2 Legal person ID card

3 Production, quality management personnel academic certificates

4 Production management, quality inspection positions of practitioners, academic qualifications, titles list

5 Plant lease contract and supporting documents

6 The main production equipment and testing equipment

p>7 Medical devices Quality management and program documents

All of the above have, in order to produce and operate.