CQC issued a notice on
CCC Medical Devices Certified on year 2003 and 2008
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.
arrange certified product to accept re-assessment for the certified holders of
2003 and 2008.
the certificates issuing on 2002 and 2007, and not yet finished re-assessment,
please concerning the related process to avoid to affect the validity.
the certificates has shown validity, please arrange to accept re-assessment
according to that shown date.
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