Category: NMPA (CFDA) Updates

The NMPA announced its preparation of “Technical Review Guideline of Diagnostic Software for Diabetic Retinopathy (DR)” and “Technical Review Guideline of Image Ultrasonic Diagnostic Based AI

China’s UDI system for the submission of the first group of devices will take effect on January 1, 2021. For the medical devices listed in the

Historical changes of medical device industry has been made in China. Amendment of the Regulation on the Supervision and Administration of Medical Devices was adopted

A “Beijing Medical Ethics Committee (EC) Review Mutual Recognition Alliance” was formed on December 1, 2020. The mutual recognition alliance currently consists of fifteen member

Unapproved medical devices can be clinically used in China’s Big Bay Area of Guangdong, Hong Kong, and Macao with over 70 million people. As long

The NMPA granted Innovation Approval for a Peripheral Drug-Eluting PTA Balloon Catheter produced by Zylox Medical on November 11, 2020. For the NMPA Innovation Device Review

“The designated medical institutions in the region can use medical devices that are urgently needed for clinical use, and have been purchased and used by

NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostic (IVD) (draft)” for comments on November 25, 2020. Feedback needs to be submitted by

The NMPA (CFDA) issued the “Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation)” (No. 77 of 2020) on

NMPA granted Innovation Approval to the Colorectal Cancer Detection Kit, Combination Detection Kit for KRAS Gene Mutation and BMP3/NDRG4 Gene Methylation and FOBT (PCR fluorescent