February 20, 2017

China Targets Sterile Devices, Implants, and IVDs for Inspection

In the previous column, we discussed China’s fast track approval process for innovative medical devices and how products can qualify under a new guideline issued in December 2016. Here we […]
February 8, 2017

China’s Fast Track for Innovative Medical Device Approvals

CFDA issued a new guideline for document preparation of innovative medical device special approval process on Dec. 15, 2016. The initial general decree that governs the general requirements of innovation […]