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China Update: Announcement No. 124 of 2022; Draft Guidelines for the Registration of Implantable Medical Devices

Chinese regulators issue regulations for enterprises’ management of medical device safety, plus draft guidelines for the registration and review of implantable medical device batteries.

China Update: IVD classification rules, medical device self-testing requirements

January 6, 2023

The China National Medical Products Administration (NMPA) and Center for Medical Device Evaluation (CMDE) published new rules for the supervision and management of enterprises implementing medical device safety, as well as draft guidelines for the registration and review of implantable medical device batteries.

Announcement No. 124 of 2022

Following the draft consultation in November 2022, the NMPA announced the issuance of the Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility for the Quality and Safety of Medical Devices, which will come into force on March 1, 2023. This requires medical device registrants and record filers to fulfill the main responsibility for medical device quality and safety.

It also includes provisions that emphasize the implementation of responsibilities for medical device registrants, filers, and entrusted manufacturers and personnel in key positions of quality and safety in medical device production and operating enterprises.

The Interpretation of Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility for the Quality and Safety of Medical Devices further discusses the provisions of the Regulations.

Draft Guidelines for the Registration and Review of Implantable Medical Device Batteries

The CMDE has issued a notice opening the public consultation of the draft Guidelines for the Registration and Review of Implantable Medical Device Batteries, which will standardize the technical review requirements and provide guidance for the application/registration of enterprises. Any comments or suggestions must be sent via email before January 6, 2023.

Emergo by UL will post updates to the guidance as they become available.