China FDA Two-track Medical Device Testing Policy May be Coming

EMERGO SUMMARY OF KEY POINTS:

• The China Food and Drug Administration (CFDA) may soon launch a two-track in-country testing pathway for medical devices.
• A possible commission testing option would cost registrants a fee but allow a potentially faster testing process.
• No official CFDA rollout of the new testing policy has occurred yet.

Medical device regulators at the China Food and Drug Administration (CFDA) may begin accepting paid commission testing in lieu of in-country registration testing to reduce application review bottlenecks.

According to Emergo consultants in Hong Kong, CFDA registrants may soon have two in-country device testing options:

• CFDA registration testing: Chinese regulators stopped charging fees for this testing in March 2017. If a registrant’s device fails any part of this process, however, that registrant will have to rejoin the back of the queue for retesting.
• Commission testing: In this scenario, fees would be assessed for testing. A registrant whose device fails any part of this process will have the chance to address the issue and resume the test, avoiding having to restart the process at the back of the queue.

Although CFDA has yet to officially announce the new testing policy, medical device registrants should be aware of the possible new policy, as well as the possibility that local test centers may prioritize devices signed up for commission testing, a paid service, over those undergoing registration testing.

Emergo will provide additional updates on the CFDA in-country testing situation as we learn them.

Related Chinese medical device market resources from Emergo:

• China CFDA medical device registration consulting
• CFDA clinical and testing requirements assessment
• Video overview: Chinese medical device regulations
• Whitepaper: CFDA medical device registration requirements