While the Novel Coronavirus (COVID-19) has caused a tragic loss of life in China, the crisis demonstrates the flexibility of the country’s health agency. In just a couple of weeks, dozens of essentials detection kits, medical devices and supplies received accelerated regulatory approval.
Thankfully, the outbreak appears to be contained and could be over by April, according to Academician Zhong Nanshan in a February 11 Reuters interview. As the crisis winds down, this incident may have a variety of implications on medical device manufacturers, including lessons for expedited market entry, a greater push for electronic document submission and challenges to ongoing clinical trials. more…
NMPA CMDE (Center for Medical Device Evaluation) published Evaluation Reports for 23 innovative devices in 2019, aiding manufacturers on the vital points to obtain market approval, while committing itself for greater transparency and efficiency. more…
NMPA announced seven recalls in January 2020:
For causes and model numbers of the recalls in January, please email info@inspirativemed.com
For Decree 29 Measures for the Administration of Medical Device Recall, please email us also. We charge nominal fees for the translation.
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…
