Feb 7, 2018
EMERGO SUMMARY OF KEY POINTS:
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:
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.
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS: