CFDA Updates

May 25, 2017

CFDA Update: Actions Taken to Deepen Registration Reform

In this month, CFDA released three documents for public comment: 1) Policies on Reforming Clinical Trial Management for Encouraging Pharmaceutical and Medical Device Innovation; 2) Policies on Accelerating Review and Approval Process for Encouraging Pharmaceutical and Medical Device Innovation; 3) Polices on Implementing Full Life-Cycle Management for Encouraging Pharmaceutical and Medical Device Innovation. According to the CFDA, these three documents aim to further deepen registration reform, promote industrial upgrade and innovation in the pharmaceutical and medical device sector, and meet increasing clinical needs. 

Contact China Med Device (CMD) team if you would like to know more about CFDA's registration and policy reform and get immediate help to accelerate your device's market entry in China. Please call us 978-390-4453 or email info@ChinaMedDevice.com.

Click here to find out more about CMD's turn-key China regulatory services for your medical device. 

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 […]