Medical Devices

China’s NMPA has released updated inspection principles for medical device clinical trials, effective May 1, 2025. Discover key changes, risk categories, and compliance strategies.

China’s 2025 Action Plan signals wider market access and policy support for foreign enterprises, including medical device manufacturers.

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

China Medical Device QMS Self-assessment Annual Report must be submitted by March 31, 2025, to avoid sales suspension, fines, and certifica...

In December 2024, China’s NMPA issued a notice regarding adjustments to the classification codes for in Vitro diagnostic reagents.|In December 2024, China’s NMPA issued a notice regarding adjustments to the classification codes for in Vitro diagnostic reagents.

On January 10, 2025, the NMPA released Chinese medical device regulatory data for 2024. This publication, which reflects data up to Dec...|On January 10, 2025, the NMPA released Chinese medical device regulatory data for 2024. This publication, which reflects data up to Dec...

One of the primary objectives of China's centralized procurement mechanism is ensuring that the medicines and medical consumables...|One of the primary objectives of China's centralized procurement mechanism is ensuring that the medicines and medical consumables...

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

On October 21, 2024, the NMPA of China provided an overview of the current status of pediatric IVD reagents in the country, highlighting...|On October 21, 2024, the NMPA of China provided an overview of the current status of pediatric IVD reagents in the country, highlighting...

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...

2024 IVD Reagents Clinical Trial Exemption Catalog draft has been announced by the CMDE on November 4, 2024, and opened for public consultation|2024 IVD Reagents Clinical Trial Exemption Catalog draft has been announced by the CMDE on November 4, 2024, and opened for public consultation