What is the product testing for
Before the time you submit the record or registration application for your medical device, the test report of your product is one of essentially required dossiers, which give the evaluation and statement for the safety and effectiveness of your product during the use.
For Class Ⅰ medical device, the product testing can be completed by your own technical department and hand in the self-inspected report when submitting the record application.
For Class Ⅱ & Ⅲ medical device, the product testing has to be completed through medical device inspection institutes which are assigned by China Food and Drug Administration (CFDA). If your product is not involved in the inspection catalogue issued by the institute, that is, the institute is unable or illegal to give the test report for your device; in this case, you shall apply for the inspection request to State Drug Administration (SDA) and follow the indication.
For imported products, foreign establishment must designate the China agent to be responsible for above product testing procedure.
The followed table specifies the procedure of product testing. Please click here for more details.
For more product testing questions, please feel free to contact us for your convenience.