Blogs

May 2, 2017

What are the Requirements for CERs in CFDA Medical Device Registration?

China introduced new requirements for clinical evaluation reports in 2015. Understanding the China Food and Drug Administration’s new CER requirements can help companies to be better prepared in their CFDA […]
April 24, 2017

CFDA Updates 2017.04.01

1 new guideline and 40 new industry standards have been released by CFDA from April 1st. Even though they are called guidelines, once they are released, you are expected to comply with them […]
April 12, 2017

CFDA Updates 2017.03.22-2017.03.24

3 new guidelines have been released by CFDA from March 22rd to March 24th. Even though they are called guidelines, once they are released, you are expected to comply with […]
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 […]