The product technical requirements, we call it product standards also, which mainly involves the performance index and corresponding test method. To compile the product standard, you shall include items as follows:
- Name
- Model and/or Specification
- Performance Index
- Test Method
- For Class Ⅲ IVD products, the product standard shall include the raw materials, production technique and semi-manufactured goods as appendixes.
Let's take imported class I medical device as an example, the dossier requirements includes:
6. certificate of analysis or self-test report
1. business license
2. overseas listing license
certificate of free sale to overseas(China)
3. production license/GMP
4. EC-certificate
5. technical specification/a methoden of final product test
7. biocompatibility test
8. process description
9. letter of authorisation from the Chinese agent
10. instruction of use
11. primary packaging
12. a letter of commitment from the agent
13. China agent's business license
