Filing of class I MDs
1. Filing form for Class I MDs
2. Safety risk analysis report
3. Product technical requirements
4. Test report
5. Clinical evaluation data
6. IFU and label design for minimum marketing unit.
7. Information about production
8. Certificates
9. Statement of compliance
Regulation:
CFDA circular about issues related to the filing of class I MDs (No. 26)
Registration of Class II and III MDs
1 Licenses and certificates
ü Business license
ü Manufacturing license
ü Marketing license
2 List of essential requirements for the safety and effectiveness of medical device
3. Product overview
ü General
ü Product description
ü Model
ü Description of packing
ü Indications and contraindications
ü Introduction of similar / previous products (if any)
ü Other information to be specified
4. Research data
ü Studies on product properties
ü Studies on biocompatibility
ü Studies on Bio-safety (if applicable)
ü Studies on sterilization and disinfection process (if applicable)
ü Studies on shelf life and packing (If applicable)
ü Animal studies (if applicable)
ü Studies on software (if applicable)
ü Other (if applicable)
5 Information on manufacturing
ü Flow Chart
ü Manufacturing Site(s)
6 Clinical evaluation documents (if applicable)
7 Product risk analysis report
8 IFU
9 label copy
10 Letter of Authorization for Agent
11 Declaration of Conformity
12 Product technical requirements
13 Registration test report
14 Application form
Regulation:
CFDA circular about registration approving
work standard of domestic class III MDs and imported MDs.