News

Cosmetic Product Safety Assessment Report now required in China from May 1, 2025. Learn how to meet the latest NMPA compliance standards.

NMPA released a draft revision on April 7, 2025, impacting classification rules for medical devices in China. Submit feedback by May 7.

Learn about China's April 2025 CMDE guidance on metal bone needle products and how it affects international orthopedic device manufacturers.

Beijing and Shenzhen implement new policies to fast-track access for innovative drugs and devices in China.

China's new cosmetic safety measures require companies to conduct risk monitoring, data reporting, and comply with NMPA's updated framework.

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

NIFDC released a Q&A on cosmetics safety data to help companies reduce assessment costs and meet China’s compliance requirements.

China’s 2024 Annual Report on Drug Adverse Reactions reveals a rise in serious cases, including those involving imported drugs.

China's Category C drug list, launching in September 2025, offers a new commercial insurance-based payment path for innovative drugs.

China has released GB 25596-2025, the updated national food safety standard for infant formula for special medical purposes.

China’s GB 17945-2024 standard for emergency lighting and evacuation systems, key to emergency lighting compliance, takes effect May 1, 2025.

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.

The Center for Drug Evaluation (CDE) in China accepted over 19,500 drug registration applications in 2024. Learn how evolving regulatory trends impact pharmaceutical market access for international companies.

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

Learn about the new standards of the Chinese Pharmacopoeia 2025 Edition, implemented Oct 1, 2025, as well as relevant compliance strategies.

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 2024 national drug sampling covered 136 varieties and 20,604 batches, achieving a 99.4% compliance rate.

On March 17, 2025, the NMPA published a draft revision of the GMP Annex for Sterile Pharmaceuticals. Overseas manufacturers must align with the new requirements to ensure compliance and continued market access in China.

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.