China Relaxes Review Process for Innovative Medical Devices

China’s Food and Drug Administration (CFDA) is removing a requirement that Innovative Medical Devices—defined as new technologies not available in China—must have regulatory approval in their country of origin to qualify for registration. Manufacturers of these devices will no longer have to provide proof of overseas marketing approval or of overseas sales. The new rules mean that manufacturers now have the option of targeting China for first regulatory approval globally. The change also shows how China is actively promoting medical technology innovation so that more Chinese patients can benefit.

For registration of Class II or Class III devices, manufacturers will now be able to choose to take the conventional in-China testing route or to submit test reports from accredited third party institutions, possibly supported by in-house data. Despite the streamlined process, manufacturers must still establish a Chinese Product Technical Requirement—a core document in the CFDA registration submission—which draws on Chinese national and industry standards.