The China Food and Drug Administration (CFDA) issued guidelines (Chinese) for manufacturers seeking to register medical device software, including stand-alone and component software. The new guidelines list standardized technical review requirements for new registrations, as well as general guidance on items to be included in the registration dossier.
Under China’s regulatory system, medical device software includes independent software and software components. Independent software refers to medical device or accessory software, and the software component refers to the software as a medical device or parts, accessories thereof.
Previously, China required medical software to be registered as a component of a medical device. China did not have regulations for registering stand-alone software.