Technical Support for Product Pre-test and Rectification in China

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.

In order to pass the medical device registration test smoothly, CIRS can assist companies in selecting a third-party testing agency for pre-testing before the registration test, and rectifying the problems found, which can greatly increase the probability of the product passing the registration test and also save the time required for rectification during registration and testing.

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.