1. Testing Object
The Classes II and III medical devices should do registered testing, but ClassⅠdo not need.
2. Preparation before Testing
Samples manufactured in compliant with the GMP.
Product technical requirements.
Products-related technical materials.
3. 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.
Choice Testing Center:
Visit CMDE’s website and click the active bar at the bottom right which says“Test Directory of Test Center”. Enter the name of product or facility, and click “Search”.
Communicate with the testing facilities directly.
4. 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.
5. Q&A
Q1. What if Testing Center Unable to Test?
A1. The medical devices that haven’t been listed in the Test Scope of testing center may be tested by the qualified testing center designated by the Department of Medical Device Registration, NMPA or provincial Medical Administration Department. Or the applicant/registrant may submit application for testing by the qualified testing center to Department of Medical Device Registration, NMPA, and implement per approval contents after being approved.
Q2. How to deal with the products applying for registration that have multiple models?
A2. The models tested in the same registered unit within which safety and effectiveness of other products may be represented.
Q3. Can the samples to be tested be manufactured by an entrusted party?
A3. For the domestic medical devices that have passed the special approval application for innovative medical device, sample production can be entrusted to other enterprise with relevant qualification. For the domestic medical devices that are not applicable to the special review and approval procedure for innovative medical device, the sample production cannot be entrusted to other enterprises.
6. Tips
Upon application for registration, the pre-evaluation opinions shall be submitted with test report.
