CFDA Updates

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 […]
August 11, 2017
innovation

Interpretation to the Relevant Issues about the Fast Approval Track for Innovative Medical Devices

China Food and Drug Administration (CFDA) pays high attention to the innovation and development of medical device industry. In order to better implement the “Fast Review and Approval Track for the […]
August 10, 2017

June 2017 CFDA Medical Device Registration and Review Report

CFDA Application Acceptance According to Insight-China Pharma Data, a total of 304 medical devices registration were accepted in June 2017 (counted by numbers of acceptance), which stayed at the lowest […]