[Discussion about Supervision Model of Customized Medical Device].

Customized medical devices differentiate in product design, manufacturing, usage, and a few other aspects in the product's life cycle. Customized medical devices should have special regulatory requirements. Through introducing the relevant regulations, policy and control measures for customized medical devices in different countries, this article intends to summarize the common characteristics of customized devices. Also, considering the development of fixed denture and medical device regulations in China, we aim to provide reference for investigators by discussing regulatory categorization in the definition and management, quality system, clinical evaluation and the post-marketing use of customized medical devices in our country.