CFDA Exempts Some Class II Devices From Clinical Trials, Beefs Up Inspections

The China Food and Drug Administration has published a list of roughly 130 Class II devices that are exempt from submitting clinical trial data. Registration submissions for exempted products should include a detailed comparison of the device and a predicate device that is already on the market. Manufacturers should provide the principle of operation, product material, physical structure and components, main technical performance index, sterilization or disinfection method, if needed, intended use and whether the device is for home use, says Jack Wong, director of regulatory affairs for Asia Pacific at Terumo’s Singapore branch.
International Medical Device Regulatory Monitor