China FDA Proposes New Medical Device Clinical Trial Exemptions
EMERGO SUMMARY OF KEY POINTS:
- Chinese medical device regulators are proposing new clinical trial exemptions for certain Class II and Class III devices.
- The draft CFDA exemption lists include 22 Class II and six Class III devices.
- Manufacturers have until June 20, 2017 to comment on the proposed CFDA exemptions.
Regulators at the China Food and Drug Administration (CFDA) have released drafts of new clinical trial exemption lists for several moderate- and high-risk devices.
The CFDA draft lists (link in Chinese) include 22 Class II and six Class III devices that, if approved by the regulator, would no longer have to undergo clinical trials in China in order to obtain market authorization. However, Chinese market registrants should bear in mind that the CFDA may amend these lists before finalizing them.
Class II devices in the new lists include insulin syringes, dental devices and surgical instruments. Class III devices listed include bone cements and orthopedic screws.
The CFDA will accept comments from industry and other stakeholders on the draft lists through June 20, 2017. The regulator last expanded its list of devices exempt from clinical trial requirements in September 2016.