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 […]
January 24, 2017

Register for the Webinar! China Medical Device Regulatory Changes

With international trade and trade relations becoming a hot topic in the news as a new president takes his seat in the White House, those manufacturers who currently do business […]
November 10, 2016

Life Sustaining Ventilators Clinical Evaluation Guidelines for Feedback Draft

If you need to provide feedback to CFDA, please let us know and we will consolidate and send it for you.  Please email to . If you want to email […]
October 3, 2016

CFDA QMS Draft Guideline for Feedback: Incoming inspection, manufacturing process and finished goods

I am sharing a response I posted to a question by a manufacturer RA. The Guideline was issued on Sept 21 for further feedback and asked all feedback be emailed […]