January 29, 2020

NMPA Finalizes Tumor Mutation Reagents Guideline for CDx

NMPA (CFDA) published the Registration Technical Review General Guideline for Performance Evaluation of the Reagents Used for Tumor Related Genetic Mutation Test (high-throughput sequencing) on December 5th, 2019. The draft guideline was issued on […]
January 29, 2020

Urgent Needs of Medical Products to Combat 2019 Novel Coronavirus

China national NMPA informed local NMPAs on Monday Jan 27 to allow import none -NMPA approval devices but have FDA approval, CE mark, or Japan approval, to help conquer 2019 […]
January 23, 2020
medical device clinical trial phrases

Medical Device Clinical Trial Phases in China: A Practical Step-by-Step Guide

Going through China’s medical device clinical trial phases can be painstaking in terms of the cost and time. While more and more clinical exemptions have been issued by China’s NMPA […]
January 23, 2020

NMPA Final Guideline on How to Address “Submission Deficiency” in China

NMPA published the “Medical Device Submission Document Administrative Measures during the Supplement Phase” (final) on January 16, 2020. NMPA issued the draft version on November 11, 2019 for public opinion. […]
January 17, 2020

Nucleic Acid Amplification Detection Analyzer from Domestic Manufacturer Gains Approval

NMPA granted Innovative Device Approval to nucleic acid amplification detection analyzer, manufactured by Hangzhou Yousida, on December 30, 2019. This product is based on the technology of three-stage magnetic permeation […]