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Notice on Re-assessment for CCC Medical Device Certified on 2004 and 2009
Public Time:2013-01-23

To those related companies,

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.

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

Contact information

Product Certification Department  V

Contact to: Qi Lina

Tel : 0086-10-83886472

                                                                          China Quality Certification Centre

                                                                                           Jan. 23rd . 2013

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