China has accelerated the Emergency Approvals under the threat of Novel Coronavirus (“2019-nCoV”). National NMPA granted seven Emergency Approvals to Coronavirus Nucleic Acid Detection Reagent manufacturers in January, while provincial NMPA offices paid all-out efforts to help contain the virus. more…
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 provincial NMPA issued the Test Report for the First Novel Coronavirus Nucleic Acid Detection Kit, describing the procedure of expedited regulatory process in the coronavirus pandemic: more…
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 August 14, 2018. more…
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 (in fact, a total of 1,002 medical devices and 401 IVDs are now exempt from clinical trials in China since the first exemptions catalog published in 2014), higher-risk devices and devices with new design, new mechanism and new materials are still required to pass clinical trials in China. more…
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
