News

China updates mandatory certification rules for electric bicycles. New standards take effect April 2025. GB 17761-2024 mandatory by Sept 1.

China approves sakura polyphenols and black wheat pollen. Understand the impact on international market access and compliance with Cisema.

New CDE policy simplifies TCM registration from HK and Macao into mainland China under NMPA Announcement No. 7 of 2025.

Taiwan restricted cosmetic ingredients list updated: TFDA bans boric acid and tightens dye limits by July 2026.

Explore Cisema’s expert insights from Europe and Asia on AI in healthcare and regulatory pathways approval in China's Greater Bay Area.

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.