March 27, 2017

CFDA Updates 20170313-20170317

7 new guidelines have been released by CFDA from March 13rd to March 17th. Even though they are called guidelines, once they are released, you are expected to comply with […]
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 […]