China revises registration procedure for imported and high-risk domestic devices:
This article was originally published in Clinica
China's State Food and Drug Administration (SFDA) has revised the standard registration procedure for all imported medical devices and domestic class III (highest-risk category) devices. Registration now comprises three elements: application acceptance by the SFDA's administrative service centre; a technical assessment, conducted by its Center for Medical Devices Evaluation; and the SFDA's administrative approval. It also specifies registration criteria and time limits, according to a summary statement issued by the agency on July 30.