IVDs

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

NMPA’s 2025 IVD Catalogue is now in effect with key changes for overseas registration. Contact Cisema for expert support.

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

China has released an IVD reagent classification catalogue. It was issued by the NMPA and includes all IVDS except those used for blood screening and those labeled with radionuclides.

China medical device registrations 2023 annual report has been issued by the NMPA.

China’s NMPA has released revised guidelines on preparing IVD IFU (Instructions for Use) by CMDE on January 3, 2024.

Coronavirus product manual changes are required by the NMPA in China. Notice No. 349 (2023) outlines important modifications for Coronavirus nucleic acids, antigens, and antibodies detection reagents.