CFDA Updates

March 24, 2017

Clinical Evaluation Reports or Clinical Trials?

China’s new requirements for CERs (Clinical Evaluation Reports) and CTs (Clinical Trials) have now been in place for more than two years.  Understanding the difference and their appropriate use can […]
March 6, 2017

CFDA Updates 2017.02.10-2017.02.16

China is back from its >10 days national new year celebration.  CFDA is busy releasing more guidelines now.  Since February 10th, 2017, six have been released. Even though they are […]
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 […]