Registration Procedure for Imported Product of Class II,III
|
1 |
Signing of Registration Agency Agreement |
|
2 |
Document Preparation and Translation |
|
3 |
Technical Requirement Compiling and Validation |
|
4 |
Product Test |
|
5 |
Clinical Trial (if necessary) |
|
6 |
Material Submission and Acquisition of Acceptance Notice |
|
7 |
Technical Review in Review Center |
|
8 |
Material Supplement |
|
9 |
Technical Review in Review Center |
|
10 |
CFDA Administrative Review/Approval & Certificate Release |
Registration Procedure for Domestic IVD Product
|
1 |
Signing of Registration Agency Agreement |
|
2 |
Document Preparation |
|
3 |
Technical Requirement Compiling and Validation |
|
4 |
Product Test |
|
5 |
Clinical Trial (if necessary) |
|
6 |
Material Submission and Acquisition of Acceptance Notice |
|
7 |
Technical Review in Review Center |
|
8 |
Material Supplement |
|
9 |
Technical Review in Review Center |
|
10 |
CFDA Administrative Review/Approval & Certificate Release |
|
1 |
Signing of Filing Agency Agreement |
|
2 |
Document Preparation and Translation |
|
3 |
Technical Requirement Compiling of Filing Product |
|
4 |
Filing Material Submission |
|
5 |
Success of Filing and Acquisition of Filing Certificate |
