IVDs

Indonesia revises medical device and IVD registration timelines under Permenkes 11/2025, extending approval timelines.

Malaysia MDA's Draft 7th Edition labelling requirements introduce broader e-labelling requirements and stronger accessibility standards.

Latest NMPA drafts propose expanding Unique Device Identification (UDI) rules to nearly all medical devices by 2029.

NMPA’s draft guide defines medical device registration self-testing and self-checking for Class II and III devices under China’s QMS rules.

Malaysia and China launch a regulatory reliance pilot to streamline IVD medical device registration and accelerate cross-border market access.

China’s 2025 IVD clinical trial exemption catalogue expands to 445 products, affecting clinical evidence requirements and IVD registration in China.

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

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 has released updated inspection principles for medical device clinical trials, effective May 1, 2025. Discover key changes, risk categories, and compliance strategies.

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.

On October 21, 2024, the NMPA of China provided an overview of the current status of pediatric IVD reagents in the country, highlighting...|On October 21, 2024, the NMPA of China provided an overview of the current status of pediatric IVD reagents in the country, highlighting...

2024 IVD Reagents Clinical Trial Exemption Catalog draft has been announced by the CMDE on November 4, 2024, and opened for public consultation|2024 IVD Reagents Clinical Trial Exemption Catalog draft has been announced by the CMDE on November 4, 2024, and opened for public consultation