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Canada
 HEALTH
CANADA REVISES GD-210 ISO 13485 GUIDE
Tunney's Pasture, Ottawa, CANADA,
31 January 2007. Health Canada issued a revision
to the GD-210 guide to applying ISO 13485:2003. The GD-210 Guide is used
by virtually all CMDCAS registrars in auditing medical device manufacturers
holding or planning to apply for Class 2 through 4 medical device licenses.
For more CMDCAS/ISO 13485 information,
click here.
ORION DELISTED AS CMDCAS REGISTRAR
Tunney's Pasture, Ottawa, CANADA,
10 June 2005. Health Canada issued a cessation
notice, the first of its kind, concerning the CMDCAS recognition of Orion
Registrars. Existing quality systems certificates will continue to be
recognised for device licensing, but no new licenses or amendments against
certificates issued after today will be accepted by Health Canada.
Medical device manufacturers which were certified by Orion
will be contacted by Health Canada and apprised of their options. For more
CMDCAS/ISO 13485 information, including a list of CMDCAS recognised registrars,
click here.
HEALTH CANADA
RELEASES PRIVATE LABEL MEDICAL DEVICE GUIDANCE
Tunney's Pasture, Ottawa, CANADA,
2 June 2005. Health Canada released new rules on
how medical devices which are privately labeled for another company are to be
licensed. The new rules go into effect immediately with a deadline of
December 1, 2005 for all private label manufacturers to apply for a new private
label device license referring to the original manufacturer's license. The
private label manufacturer does not require ISO 13485 registration, unlike the
OEM. However, private label manufacturers without a valid CMDCAS ISO 13485
registration are subject to inspection by Health Canada. In order for the
private label license to be issued, a signed attestation by the original
manufacturer must be submitted. For
more information on this topic, or to
obtain copies of the specific documents,
click here.
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