关键词: font-size:medium, ">增材制造；个性化医疗器械；上市前监管

Abstract: Additive manufacturing of personalized medical devices is hot study area and one of the key points of regulatory scientific research. This article comprehensively reviews the current regulatory status of personalized medical devices in additive manufacturing in China， including regulatory requirements such as definition， regulatory mode and classification management， technical guidance and standard system. In addition， combined with the International regulatory research and technology development， this paper puts forward the new problems and challenges to provide reference for relevant personnel.

Key words: font-size:medium, ">Additive manufacture；Personalized medical devices；Pre-market administration