National Health Commission: Unregistered medical devices can be used directly in emergencies

On December 15, the official website of the NMPA issued a notice on the release of the “Emergency Use Management Regulations for Medical Devices (Trial)”.

Announcement content：

In order to make a good emergency response to particularly major public health emergencies and other emergencies that seriously threaten public health, guide and regulate the emergency use of medical devices, in accordance with the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of The State Council), The NMPA, together with the National Health Commission and the National Disease Control Bureau, has formulated the Provisions on the Administration of Emergency Use of Medical Devices (Trial Implementation), which are hereby promulgated and shall come into force as of the date of promulgation.

NMPA

National Health Commission

National Disease Control Bureau

November 23, 2023

Summary of provisions:

 The Regulations on the Management of Emergency Use of Medical Devices (Trial Implementation) are specially formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices for the purpose of handling especially major public health emergencies and other emergencies that seriously threaten public health and guiding and regulating the emergency use of medical devices. When there is a particularly major public health emergency or other emergency that seriously threatens public health, in order to meet the needs of prevention and control of the incident, after research and demonstration, medical devices that meet the requirements of these Provisions may be used urgently within a certain range and time limit.

Source：National Health Commission of the People’s Republic of China

Translated & edited： Bradyknow