Blogs

January 3, 2018

New CFDA Guidelines on 12 Categories of Medical Devices

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 them whether your products are […]
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 […]