December

December 29, 2017

CFDA Approved In-Vitro Diagnostic (IVD) Reagents For Liver Cancer Detection

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 […]
December 27, 2017

Transenterix Forges a Local Partnership to Commercialize Its SurgiBot System in China

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 […]
December 26, 2017

Unidiag Completed Its Series A+ Round

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 […]
December 23, 2017

CFDA Greenlighted A Treatment of Chronic Heart Failure in China

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 […]
December 22, 2017

Regulatory Affairs Event with CFDA Delegates a Success!

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 […]
December 22, 2017

China Announced The World’s Second Largest Medical Device Market

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 […]
December 21, 2017

China’s Rapid-Growing Mobile Healthcare Market: Current and Future

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 […]
December 20, 2017

Why Is It Taking One Year to Migrate to China’s New Medical Device Classification System?

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 […]
December 19, 2017

Stratasys and GE Healthcare China Form Strategic Partnership

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 […]
December 16, 2017

CFDA Released China Medical Device Registration Unit Classification Guidelines

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 […]
December 14, 2017

Ambient Clinical Analytics Expands Into China

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 […]
December 11, 2017

AI-Aided Diagnosis A Focus Under the New CFDA Medical Device Classification

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 […]