Regulatory News from Across Asia-Pacific

China will enforce new safety standards for household electrical appliances starting August 1, 2026. Learn how GB/T 4706.1—2024 impacts manufacturers, importers, and compliance requirements.

Stay compliant with China’s latest regulations on pet disease antigen screening. Learn how MARA classifies veterinary diagnostic products and what it means for businesses.

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.

The China Certification Centre for Automotive Products (CCAP) has extended certification validity for select automotive products from 5 to 10 years, effective December 31, 2024. Learn how this impacts manufacturers and compliance processes.

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

CNCA issued Announcement No. 28 of 2024, releasing updated Implementation Rules for Mandatory Product Certification: Motor Vehicle Tires...

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 2025, National Medical Products Administration (NMPA) issued the "Several Provisions on Supporting Innovation in Cosmetic Ingredients...

The NMPA issued a draft policy aimed at simplifying the registration and approval process for traditional oral Chinese patent medicines...|The NMPA issued a draft policy aimed at simplifying the registration and approval process for traditional oral Chinese patent medicines...

The NHSA has released the 2024 National Medical Insurance Drug List (NEDL) and launched updates regarding this year’s drug price....

The Center for Drug Evaluation (CDE) issued Traditional Chinese Medicine clinical development guidelines on November 19, 2024....

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.

The China CDE has released new guidelines on biosimilars, Mediterranean anemia gene therapies, and patient-reported outcomes in rheumatolo...

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...

The CDE has released three key guidelines, between September and November 2024, aimed at providing technical direction…|The CDE has released three key guidelines, between September and November 2024, aimed at providing technical direction…