CFDA Updates

January 10, 2018

CFDA Issued Registration Technical Review Guidelines for Mobile Medical Devices

1. Scope This guideline applies to the application registration of class II and III mobile medical devices. 2. Mobile Medical Device (1) Definition of Mobile Medical Device A “mobile medical […]
January 8, 2018

Take Advantage of CFDA’s Priority Channel For Your Medical Device

As part of CFDA’s implementation of reforms to its approval systems for drugs and devices and to meet the clinical demands of medical devices, CFDA opened up its priority review […]
January 5, 2018
Webinar Icon

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 […]