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 seek
6. Product manuals and labels 154
8 production and manufacturing information 963
9 Clinical evaluation information 2616
II. Class I medical device production record;
1 business license, organization code copy
2 legal person ID card
3 production, quality management personnel education certificate
4 production management, quality inspection position practitioners, education, title list
5 plant lease contract and supporting documents
6 main production equipment and testing devices
p>7 medical device quality management and program documents
All of the above have, in order to produce and operate.