January

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 […]
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 […]
January 9, 2020

NMPA: Industry Standards Changes in December

NMPA changed status of forty industry standards from “Mandatory” to “Recommended” in December 2019. Although both mandatory and recommended standards are not legally binding, manufacturers better to comply with them […]
January 8, 2020

Conditional Approvals with Limited Clinical Data Apply for Critical Devices, New NMPA Guideline Says

NMPA recognizes the urgent need for certain devices and IVDs. Those indicated for life-threatening illnesses can be granted Conditional Approval if the benefits of the product outweigh the risks. The […]
January 8, 2020

Eight Class III Categories that Must Obtain Clinical Approval

As innovation devices and first-of-kind products flood into China market, NMPA seeks to strengthen the clinical-trial approval requirements for certain devices. NMPA published the Catalog of Class III Medical Devices […]
January 7, 2020

Expert Panel Guideline in China MedTech Issued

NMPA published the “Guideline on Expert Panel/ Public Advisory Meeting” on December 5, 2019. During the NMPA registration process, Expert Panel weigh the available evidence and provide scientific and medical […]
January 7, 2020
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About China Medical Device Classification