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 […]
September 29, 2016

Reflections on China National Day Gold Week Holiday Oct 1 to 7, 2016

Next week is a long national holiday in China, celebrating the founding of People’s Republic of China in 1949. My inbox will slow down but I know a lot of […]
September 23, 2016

What does the sweeping changes of CFDA regulations mean to your medical devices in China?

Since 2015, more than 100 regulations and laws have passed from the central government mandates to CFDA requirements biggest shakeup since 2000. The changes impact not only premarket submission but […]