Medical Devices

The NMPA has released the 2025 National Medical Device Sampling Inspection Plan. Learn about new inspection processes, reinspection rights, and compliance strategies for entering the Chinese market.

The NMPA's updated Guidelines for On-site Inspection of Medical Device Distribution took effect on July 1, 2024, replacing the 2015 version. Learn how these changes affect overseas manufacturers entering the Chinese market.

The NMPA's 2024 report introduces over 2,000 medical device standards, impacting registration and compliance for international manufacturers in China.

China’s oral healthcare market is expanding at a 12% annual rate, with dental anesthesia devices exceeding 1.8 billion yuan. Learn about clinical trends, regulatory requirements, and opportunities for international manufacturers.

China’s NMPA approved 13,133 medical device registrations in 2024, including innovative and priority-reviewed products. Learn about regulatory updates, compliance requirements, and market access opportunities for foreign manufacturers.

Learn about China's latest regulatory updates on nucleic acid testing reagents, market growth trends, and compliance requirements for manufacturers in 2025.

Learn about the latest NMPA regulatory developments affecting medical device compliance in 2024. Understand key inspection findings, risk areas, and compliance strategies for manufacturers.

Discover the latest 2025 medical device standards announced by the NMPA, including mandatory updates and compliance requirements for market access and ISO alignment.

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...