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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 property rights. This means that
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 China’s Great Belief International Limited
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 Enterprises Development Fund (Shenzhen Guozhong
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 Kedikoglou noted “this is a
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 Regulatory representatives from U.S. Medtech
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, an increase of 13% over
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 with the traditional medical, mobile
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 released on August 31 this
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 has become world’s 2nd larget
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 of application and packaging specifications
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 supports hospitals across China. In
The new “medical equipment classification directory” In recent years, the rapid development of China’s medical device industry, at present there are about 77,000 valid registration certificates of medical devices and
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