Chinese Provinces Get Class III Device and IVD Inspection and Approval Authority

Posted 01 July 2013 | By Ansis Helmanis 

The China Food and Drug Administration (CFDA) has issued a notice regarding adjustments to the duties undertaken by provincial food and drug supervision and management departments, part of an effort to implement the State Council institutional reform and functional transformation plan to further the reform of administrative evaluation and approval of medical devices.

The notice points out that as of 1 October 2013, the provincial Food and Drug Administration departments must implement Class III medical device registration certificate approvals and approval of in vitro diagnostic reagents. 

As of 1 July 2013, the provincial Food and Drug Administration departments will undertake the quality management system inspection work originally conducted by the State Food and Drug Administration Drug Certification Management Centre for Class III medical devices and in vitro diagnostic reagents.

CFDA Notice

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