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Documents required for Registration of Medical Devices by CFDA-effective since 20141001
1. Application Form
2. Evidentiary Documents
3. List of Basic Requirements of Medical Devices of the Safety and Effectiveness (STED)
4. Overview
4.1 Summary
4.2 Product Description
4.3 Type/Specification
4.4 Package Description
4.5 Indications and Contraindications
4.6 Predicated Product (If Applicable)
4.7 Other information that Need to Be Described
5. Research Documents
5.1 Performance Study
5.2 Biocompatibility Evaluation Study
5.3 Biological Safety Study
5.4 Sterilization/disinfection process Study
5.5 Shelf life and Package Study
5.6 Animal Study
5.7 Software Study
5.8 Other
6. Manufacturing Information
6.1 Manufacturing Process for Inactive MD
6.2 Manufacturing Process for Active MD
6.3 Production Site
7. Clinical Evaluation Data
8. Risk Analysis Data
9. Product Technical Requirements (specification)
10 Test Report for Registration
10.1 Test Report
10.2 Pre-evaluation Advice
11. Instructions for Use and Label Template
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