Clinical Trial Requirement Changes In the future, most Class III medical devices and some Class II

Clinical Trial Requirement Changes
In the future, most Class III medical devices and some Class II medical devices will need to have local clinical studies for approval.

In late November last year, however, the SFDA simplified the requirements for specific Class II medical devices in its “Notice for Clinical Trial Waiver Concerning Certain Class II Devices.” There were 21 different kinds of Class II devices that became eligible for waiver of local clinical trials. These
devices include: basic surgical instruments, medical electrical devices, equipment for sterilization, and devices for general examination. The SFDA aims to use this waiver to regulate the registration of Class II devices more stringently while still allowing an expedited approval for select product types.

Medical device companies applying for the waiver for Class II devices are required to submit comparison data that shows their new product’s similarity with a product already on the approved list for China. The comparison data must include: information on functional mechanisms, product materials, structural composition, primary technical performance indicators, methods of sterilization (if applicable), expected uses, and whether the products are intended for household use. It is important to note that companies should consult the SFDA or provincial authorities when preparing the comparison data for the application.