Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
As part of CFDA’s implementation of reforms to its approval systems for drugs and devices and to meet the clinical demands of medical devices, CFDA
Learn Key CFDA Premarket Submission Tips for IVD Approval Registration is closed for the webinar Wednesday, Jan. 17, 2018 · 1:30 p.m. – 3:00 p.m. EST
China’s Grand Pharmaceutical has announced that it entered into a subscription agreement with Canada’s Conavi Medical. The two companies also entered an exclusive distribution agreement
The CFDA issued 12 new guidelines on December 22nd, 2017. While they are titled guidelines, once they are officially released, you are expected to comply with
CFDA has just approved a prothrombin (DCP, PIVKA-II) and alpha-fetoprotein heterogeneity (AFP-L3) ratio of automatic chemiluminescence detection reagents, with China’s first fully independent owned intellectual
Transenterix, a US-based medical device company that builds surgical robotics to improve minimally invasive surgery, has announced that it has entered into an agreement with
Beijing Unidiag Technology Co., Ltd, a Chinese medical device and reagent developer, has raised 10M+ RMB in Series A+ round from National Small and Medium-size
The Germany-based Impulse Dynamics just announced that China’s CFDA has approved its Optimizer® system for treatment of chronic heart failure. Impulse Dynamics’ CEO, Dr. Simos
China Med Device and CABA held a quarterly Regulatory Affairs event with CFDA representatives from Beijing in Cambridge, MA on Sunday, December 10. Nearly 50
According to the statistics of China Medical Device Industry Association, in 2016, the annual output value of China’s medical device industry reached 276.5 billion yuan,
Mobile healthcare refers to the delivery of medical services and information through the use of mobile communication technologies. Achieve medical services “at your fingertips.” Compared
The newly revised Medical Device Classification Catalog (hereinafter referred to as the “Classification Catalog”) released by China’s State Food and Drug Administration (CFDA) was officially