In late August, 2020, NMPA released an announcement of the withdraw of 10 medical device registration certificates. Three of them are IVD products from Guangzhou Fenghua Biological Engineering Co.,Ltd The rest of them are medical devices from TXF Medical, Guangzhou Fenghua Biological Engineering Co.,Ltd and ResMed Ptv Ltd respectively. more…
On August 26, 2020, CMDE issued a notification that the “Pure titanium powder was formed for oral prosthesis by laser selective melting” of Xi’An Bright Laser Technologies Co.,Ltd is proposed to obtain the priority pathway approval, because this product is listed in the national key research and development plan. more…
NMPA published two Q&A on IVD equipment and hemodialyzer respectively, addressing two frequently asked issues:
Q: When applying for an in vitro diagnostic equipment registration change, is it necessary to conduct the cybersecurity registration inspection or third-party inspection? more…
On August 24, 2020, NMPA intends to allow the following applications to be subject to the innovative green pathway review procedures: TaurusOne® made by BCTC, IBS Angel™ made by Peijia Medical Limited and Gastric Bypass Stent made by TANGJI Medical.
Link: https://www.cmde.org.cn/CL0004/21526.html
Recently, the National Health Commission released a notice about its adjustment of the large medical device allocation plan from 2018-2020. The new plan will increase the number of large medical devices by 2,671, more…
On August 21, 2020, CMDE announced its preparation of Technical Guideline on the Registration of Cryptococcal Antigen Detection Reagent (draft). The “cryptococcal antigen” referred to in these guidelines is “cryptococcal capsular polysaccharide antigen”. more…
In July 2020, NMPA has approved a total of 102 medical devices. 73 of them are domestic Class III medical devices, 11 of them are imported Class III medical devices, 17 of them are imported Class II medical devices and one of them is a Taiwan medical device. more…
On August 20, 2020, CMDE announced its preparation of Technical Guideline on the Registration of Rotavirus Antigen Detection Reagent (draft). This Guideline applies to reagents that qualitatively detect rotavirus in human stool samples or other applicable samples on the basis of antigen antibody reaction. more…
