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CFDA: Changes in requirement for the approval of medical devices for the P.R. China

6. November 2013

Certain medical products and medical devices must be certified and registered by the China Food and Drug Administration (CFDA) before they can be exported to China. Until recently, CCC certification at CQC was also required for some of these products. The AQSIQ changed this policy with “Announcement 52” in April 2013, no longer requiring CCC certification (with the CQC) for medical products and devices as of May 2013. All certification for medical products and devices now falls under the CFDA certification and registration process.

This change affected the following devices: Implantable Pacemakers, Rubber Condoms, ECG Devices, Artificial heart-lung Machines, Extracorporeal Blood Circuit for Blood Purification Equipment, Hollow Fiber Dialyzers, Hemodialysis Equipment, Medical Diagnostic X-Ray Equipment.

Please click here for more information about CFDA.





















MPR Author

About the author: Julian Busch is founder and managing director of MPR China Certification GmbH
Publisher: MPR China Certification GmbH

Tel.: +49 69 271 37 69 150