January 15, 2018
Before undergoing registration application in China, medical devices shall be sent to medical device inspection agencies for examination to ensure that the products meet national standards. CFDA has issued a notice on the examination work to ensure the efficiency of registration of medical devices. The details of the notice are as follows:
- The Food and Drug Administration offices from all provinces shall actively seek the financial support of the financial institutions for the medical device inspection agencies, and shall properly ensure the funding for inspection work.
- The Food and Drug Administration of all provinces shall strengthen the supervision and administration of the medical device inspection agency affiliated with each of the provinces, including
i) acceptance of the inspection application from other provinces
ii) clear stipulation of the inspection period as stated in the examination contract
iii) completion of inspection within a reasonable working time, and
iv) issuance of the inspection report.
- CFDA starts to accept for the examination report by way of a commissioned application. However, the examination report and the technical requirements of medical devices shall meet the national standard. The applicants may entrust the medical device inspection agencies in two ways. First is by registered application, where the medical device inspection agency cannot charge any testing fee to the applicants. The second is by commissioned application, where the applicants need to pay the testing fee to the medical device inspection agency. Before, CFDA only accepts examination report which is entrusted by registered application. Now, CFDA also accepts for the examination report which is entrusted by commissioned application.
CFDA publishes the notice on examination of medical device