CFDA Updates

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 16, 2017

Interpretation to CFDA’s Quality Management of Medical Device Clinical Trials

A.   About the one-year validity period of the registration test report of medical device clinical trials Article 7 of the “Medical device clinical trial quality management practices” provides: “quality inspection […]
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 […]
August 11, 2017

Interpretation to the Relevant Issues about the Special Approval Procedure 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 “Special Review and Approval Procedures for […]
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 […]