The Clinical Exemption Catalogue has gradually expanded to continue to help reduce time-to-market for medical device manufacturers. CFDA is accepting comments and feedback from the industry, manufacturers and associations until June 20, 2016.
The principle qualification rules, which are delineated in Decree of the State Council No. 650, are as follows:
- The medical device must have definite operating principles; an established design; a mature manufacturing process; and no record of serious adverse event from substantially equivalent medical devices which have been marketed and clinically applied for years, and without changing the conventional purpose of use.
- The safety and effectiveness of the medical device can be proven through non-clinical evaluation.
- The safety and effectiveness of the medical devices can be demonstrated through the analysis and evaluation on the data obtained from clinical trials or clinical application of the substantially equivalent medical devices.
If the device in question is applicable to any of the above rules, there is reasonable room for negotiation with CFDA for the device to be included in the exemption catalogue. For example, NAMSA was able to influence the CFDA reviewer to seek for opportunity to include medical elastic stockings and wire guide on the exemption list. They are now successfully included in the draft.