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 2009, should accept re-assessment since 2013 (the certified year take certificate number as a standard, that is, the top four certificate number is 2009), and re-assessment should be finished within five years after initial issuing date. For the medical devices which got CCC certificate on 2004, should accept the second re-assessment since 2013 (that is, the top four certificate number is 2004), 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 2004 and 2009.
For the certificates issuing on 2003 and 2008, and not yet finished re-assessment, please concerning the related process to avoid to affect the validity.
