CFDA Updates

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

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 […]
August 8, 2017

A China-US Joint Meeting Held For Medical Device Clinical Trial Supervision and Exchange

In this month, a Sino-US medical device clinical trial supervision exchange meeting was jointly held by the CFDA’s department of international cooperation, medical devices management department and the U.S. Food […]
August 7, 2017

China Deepening Its Medical Device Registration and Regulation Reform

On July 19, the 37th Meeting of Comprehensively Deepening Reform Leading Group of the Central Committee of the Communist Party of China was held, which deliberated and approved“The Opinions about […]