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 extraction and fluorescent polymerase chain reaction. It is used together with the matching detection kit for the qualitative detection of M. tuberculosis complex group nucleic acids derived from human samples. more…
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 in order to expedite type testing and shorten new or renewal registration time. China Med Device, LLC has test engineers onsite at NMPA testing centers to help you. info@chinameddevice.cn
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 manufacturer must also be committed to perform further clinical research. more…
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 Requiring Clinical Trial Approval on December 23, listing these eight categories: more…
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 advice on the safety and efficacy of products that NMPA regulates. NMPA weighs the advice that it receives when taking final actions. more…
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 device clinical exemptions more consistent with internationally-accepted standard, NMPA stated in the notice. more…
Only one out of five medical devices granted Innovative Device Status by NMPA in 2019 were imported. Since domestic and overseas manufacturers have equal opportunity for this program, U.S. and European companies may not be taking full advantage. more…
“Regulation of Medical Device Clinical Trial Quality Management (so called China GCP)” issued on March 1, 2016 specifies that “Clinical trial sites must be on the NMPA filed institutions for Medical Device Clinical Trial Sites”. The new policy became mandatory on January 1, 2019. more…
You may find it complicated and confusing when trying to navigate through China’s medical device classification, registration and clinical trials process. In addition, to make the matters worse, specific regulatory documents from NMPA are only available in Chinese (you can contact us for English copies). First of all, to begin to understand the NMPA’s process, you need to know about these 4 things that matter to medical device classification and registration in China. more…
