New regulations for medical devices issued, special customized devices put forward high requirements

According to the official website of the food and drug administration, in order to meet the rare and special personalized needs in clinical practice, standardize the supervision and management of customized medical devices, and ensure the safety and effectiveness of customized medical devices, the State Food and Drug Administration and the State Health Commission jointly issued the announcement on the issuance of the regulations on the supervision and management of customized medical devices (Trial) (hereinafter referred to as the regulations).

The regulations are divided into six chapters, including general provisions, record management, design and processing, use management, supervision and management, and supplementary provisions, with a total of 35 articles. It defines the requirements for the definition, record, design, processing, use, supervision and management of customized medical devices.

Definition of personalized medical devices