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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Tuesday, Jan. 21, 2020, 11:00 a.m.-12:30 p.m. EST Sign up now Use VIP code VIP20 to receive 20% discount The National Medical Products Administration (NMPA) — formally known as the […]
NMPA published the final version of “Clinical Trial Exemptions Catalog for Medical Devices” on December 20, 2019. It is an effort to implement risk-based clinical evaluation, and to make medical […]