China Frees 8 Medical Devices from Compulsory Certification

In accordance with China regulations on certification and accreditation, medical device supervision, and compulsory product certification, eight kinds of medical devices as annexed herein shall, as of April 23, 2013, be exempted from China Compulsory Certification (CCC) and be subjected to China registration for medical devices.

The designated certification authorities shall not impose compulsory certification any more on the eight medical devices and shall revoke the concerned certificates already issued to such medical devices.

The enterprises certified for such medical devices shall return any China Compulsory Certification (CCC) marks already bought but unused to the mark issuing agencies and may be refunded therefore.


Annex: List of Medical Devices Exempted from China Compulsory Certification


The General Administration of Quality Supervision, Inspection and Quarantine of China (AQSIQ)
China Food and Drug Administration (CFDA)
The Certification and Accreditation Administration of China (CNCA)

April 23, 2013