China CCC – Reassessment for Medical Devices

According to National Implementation Rules for Compulsory Certification of Medical Device, if the certificate maintains in effective, the certified products must be re-evaluated on the fifth year after issuing date. According to this rules, for the medical devices which got CCC certificate on 2008, should accept re-assessment since 2012 (the certified year take certificate number as a standard, that is, the top four certificate number is 2008), and re-assessment should be finished within five years after initial issuing date. For the medical devices which got CCC certificate on 2003, should accept the second re-assessment since 2012 (that is, the top four certificate number is 2003), and re-assessment should be finished within five years after the end date of first re-assessment. CQC will suspend or withdraw the certificates for those fail to complete re-assessment.

Please arrange certified product to accept re-assessment for the certified holders of 2003 and 2008.

For the certificates issuing on 2002 and 2007, and not yet finished re-assessment, please concerning the related process to avoid to affect the validity.

For the certificates has shown validity, please arrange to accept re-assessment according to that shown date.