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2026 China NMPA Bluebook is here:
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
According to Gartner, 30% of internal medical implants and devices in the medical field will use 3D printing technology by the year 2020. Considering China
On November 23, CFDA issued official Guidelines on Medical Device Registration Unit Classification, which mainly focus on the technical principles, structural components, performance indexes, scope
Ambient Clinical Analytics, a U.S. medical analytics company founded in 2013, just inked a cooperation agreement with Meehealth, a leading Chinese Health IT company that