Medical Devices

China's 2025 legislative plan includes the draft Medical Device Management Law, introducing life-cycle regulation and compliance.

China’s CMDE issued Notice No. 3 (2025) to fast-track innovative medical devices and raise standards for non-innovative products.

Learn how China’s medical device master file system supports confidential documentation, protects IP, and streamlines regulatory reviews for international manufacturers.

Key outcomes from China’s 2025 Two Sessions highlight regulatory updates, innovation policies, and new market opportunities for international medical device manufacturers.

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.