To register a medical device in China, the Classes II and III medical devices should do registration testing in a testing center with related qualification.
1. Preparation before Testing
- Samples manufactured in compliant with the GMP.
- Product technical requirements.
- Products-related technical materials.
2. Select testing center
Principle: Registration testing shall be conducted in the testing center with medical device test qualification and capable of providing items for the product to be tested.
3. The Processes of Testing
- The applicant/registrant signs a contract with the testing center.
- The applicant/registrant submit product technical requirements and product technical materials , meanwhile , send the samples to be tested to the testing center.
- The testing center undertakes the testing.
- The testing center issues a test report.
According to the latest version of the "Regulations on the Supervision and Administration of Medical Devices" (Order No. 739) and the "Regulations on Self-inspection of Medical Device Registration (Draft for Comment)", registrants can try to use third-party inspection reports and self-inspection reports for product registration.