CFDA Updates

May 9, 2017

CFDA Updates 2017.04.01-2017.05.01

“Provisions for Medical Device Standards” and 4 new guidelines and have been released by CFDA from April 26th to April 27th. Even though they are called guidelines, once they are released, […]
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 […]