Medical Devices

The CMDE asks for the input from medical device manufacturers in the field of tissue regeneration for support in their research and technology development.

Following the launch of the China’s national UDI system, the Hainan MPA has announced a pilot plan for the UDI system in Hainan with a larger product scope.

Due to the 2020 performance of the fast-track approval process for medical device registration in China, the CDME plans to implement a smart review process.

3 GB standards announced; 14 technical guidelines and 2 draft guidelines were issued; 6 medical devices pending for fast-track approval

The new draft clarifies the registration requirements and categorization method of different drug-device combination products in China.

Ultrasonic coupling agents are reminded to comply with mandatory standards and any necessary filing changes must be completed by the end of February 2021.

5 new technical medical device guidelines whilst there were 4 guidelines implemented and 6 drafts are announced by NMPA

The NMPA issued the technical review guideline for medical device-based combination products, and on drug release studies required...

Document No. 53, outlining comprehensive reforms aimed at strengthening the regulation of pharmaceuticals and medical devices. These reforms..

China domestic production of imported medical devices policy has been drafted and released by the National Medical Products Administration (NMPA) on November 4 ,2024.|China domestic production of imported medical devices policy has been drafted and released by the National Medical Products Administration (NMPA) on November 4 ,2024.

The NMPA has released a draft of the ‘Good Manufacturing Practices for Medical Devices’, which is now open for public comment...|The NMPA has released a draft of the ‘Good Manufacturing Practices for Medical Devices’, which is now open for public comment...

The national standard titled "Diagnostic Techniques for Canine Distemper" has been published and is set to come into effect on June 1, 2025.|The national standard titled "Diagnostic Techniques for Canine Distemper" has been published and is set to come into effect on June 1, 2025.