Category: NMPA (CFDA) Updates

From regulatory submission to approval, it only took 2 days for a coronavirus nucleic acid detection kit to go to market. On January 28, Jiangsu

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

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

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

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

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.

NMPA announced 25 recalls in December 2019, including two Class I recalls. Class I recall (the most serious): Johnson & Johnson: Multiaxial pedicle fixation system

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

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

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

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