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 […]
January 14, 2020

NMPA News Roundup December 2019

Here’s the latest NMPA news roundup, for December 2019, affecting MedTech pros who offer devices and IVDs in China, provided by China Med Device, LLC. Forward this newsletter to a […]
January 9, 2020

Two Class I Recalls Announced in December

NMPA announced 25 recalls in December 2019, including two Class I recalls. Class I recall (the most serious): Johnson & Johnson: Multiaxial pedicle fixation system Boston Scientific: Guiding catheter Class […]