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.
CIRS has rich experience in medical device registration, registration testing, clinical trials and other related fields. We can provide our clients with product technical requirements preparation, manual and label preparation, test follow-up, test rectification and other registration test related services to assist companies in passing product registration testing, and completing the product registration.