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.