IVDs

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.

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

China radio frequency beauty devices have new technical review guidelines issued to ensure that products are safe and effective

China medical device industry standards March 2023 update covers 20 standards released by the NMPA for manufacturers to comply with.

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.

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

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

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

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

NMPA published a revised the clinical trial exemption list for medical devices and IVD reagents which became effective on October 1, 2021.