CFDA Updates

August 27, 2017

Highlights of CFDA 2016 Medical Device Registration Annual Report (Part 2 of 4)

B. The Acceptance Of Medical Device Registration Application In 2016, China Food and Drug Administration received a total of 8920 applications for medical device registration, renewal of registration and licensing […]
August 27, 2017

Highlights of CFDA 2016 Medical Device Registration Annual Report (Part 1 of 4)

1. The Work on Medical Device Registration (a) The gradual improvement of medical device registration management regulatory system The issue of the ” Quality Management Practices of Medical Device Clinical […]
August 22, 2017

CFDA Issued New Techinical Review Guidelines on Detal Implant Equipment and Soft Contact Lens

2 new guidelines have been released by CFDA on August 9th. Even though they are called guidelines, once they are released, you are expected to comply with them whether your products are in […]
August 18, 2017

More Coordinated Efforts Between US FDA and China’s CFDA On ICH

More Coordinated Efforts Between US FDA and China’s CFDA On ICH On August 9, 2017, in an FDAVoice blog post, Theresa M. Mullin, director of FDA’s Office of Strategic Programs […]
August 14, 2017

Policy Diagram: “Amendments to the Registration Management Measures of in Vitro Diagnostic Reagents”

Understanding to the “Amendments to the Registration Management Measures of in Vitro Diagnostic Reagents” The reason of the amendments: The development of in vitro diagnostic technology, the increase of usage […]