CFDA Updates

January 5, 2018
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FDANews Webinar on Jan 17: How to Get IVD Approval Through CFDA

Learn Key CFDA Premarket Submission Tips for IVD Approval Register here for the webinar Wednesday, Jan. 17, 2018 · 1:30 p.m. – 3:00 p.m. EST Marketing medical devices and IVD […]
January 4, 2018

China’s Grand Pharmaceutical and Canada’s Conavi Medical Align On Imaging Technology

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 for Conavi’s products. Pursuant to […]
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 […]
January 2, 2018

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 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 […]