China ? Clinical trial requirements for certain Class II devices eased

摘要

The Chinese State Food and Drug Administration has issued a new rule that aims to simplify clinical trial requirements for certain Class II medical devices. The Notice for Clinical Trial Waiver concerning Certain Class II Devices (Notice) was announced on 24 November 2011 and takes effect immediately, law firm Sidley Austin reports.In the notice, the SFDA has identified 21 types of Class II devices that are eligible for waiver of local registration trials, provided that the marketing authorisation applicant can produce a comparative illustration of the device under application to demonstrate equivalence to a type of device that has already been approved by agency, Sidley Austin explains.