Document Number: No. 150, 2023
On December 15, 2023, NMPA released an announcement regarding the trial implementation of emergency use management regulations for medical devices.
These regulations were formulated by NMPA to address major public health emergencies and other serious crises, providing guidance on the emergency use of medical devices.
In the event of significant public health emergencies or other serious crises, medical devices meeting the requirements outlined in these regulations can be urgently deployed within a defined scope and period to meet prevention and control needs.
The emergency medical devices for use should either be unregistered in China with similar products or registered as similar products but unable to meet the demands of major public health emergencies or other serious crises. Notably, Class I medical devices are excluded from the scope of emergency use under these regulations.
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