Medical Devices

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

On October 29, 2021, the NMPA published the In Vitro Diagnostic Reagents Classification Rules for the first time as an individual document.

Overseas clinical trial data for IVD registration in China now adopts the new technical guidelines issued on December 1, 2021, by the NMPA.

The NMPA reported a total number of 12,255 applications and 11,314 approvals for medical device and IVD registrations in 2021.

The China Clinical Trials GCP (Good Clinical Practice) 2022 amended version will come into effect on May 1, 2022.

China’s IVD reagent classification catalogue has been revised and reissued for industry comment. The deadline for submission is Apr. 12, 2023

China IVD Reagent Registration and Review Guidelines have been recently updated. Six guidelines came into effect on September 28, 2022.

IVD Reagent Registration Change Review Draft Guidelines have been issued by CMDE in draft format for industry comment by June 30, 2023.

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

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.

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...