Blogs

May 24, 2017

CFDA added more class II and class III devices to the clinical trial exempt list

On May 17,2017,CFDA issued a draft notice that the third batch of clinical trial exempt products for class II and class III devices have been added to the clinical trial […]
May 17, 2017

CFDA Updates 2017.05.02-2017.05.12

Industry Standards for 28 medical devices including “Disposable Plasmapheresis Centrifuge Apparatus” have been released by CFDA from May 2nd to May 12nd.  If you need any detailed information regarding these guidelines and how […]
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, […]
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 […]