January 23, 2020
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 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
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
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
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 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
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
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 2, 2020
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 […]
December 31, 2019
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 […]