China: Latest announcement Implementing new rules for Medical Devices safety 2022 Draft Guidelines

New regulations for the oversight and management of businesses implementing medical device safety, as well as proposed rules for the registration and evaluation of implantable medical device batteries, were published by the China National Medical Products Administration (NMPA) and the Center for Medical Device Evaluation (CMDE).

Announcement No. 124 of 2022

The NMPA announced the release of the Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility for the Quality and Safety of Medical Devices, which will enter into force on March 1, 2023, following the draught consultation in November 2022. This necessitates that medical device registrants and record filers carry out the primary duty for medical device quality and safety.

Additionally, it contains clauses that focus on the execution of duties for medical device registrants, filers, trusted manufacturers, and staff members in crucial roles for quality and safety in medical device manufacturing and operating enterprises.

The requirements of the Regulation are further discussed in The Interpretation of Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility for the Quality and Safety of Medical Devices.

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Source: NMPA