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 16, 2017

14th Annual Medical Device Quality Congress

March 28-30, 2017 • Bethesda North Marriott • North Bethesda, MD The Annual Medical Device Quality Congress is going strong on their 14thyear. The conference will be located at the […]
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 […]