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 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, including
obtaining copies of the specific documents,
click here.
HEALTH CANADA DEADLINE TO INDUSTRY:
ISO 13485/8, MDR REQUIREMENTS COMPLIANCE BY/AFTER NOV. 1, 2003
Tunney's Pasture, Ottawa, CANADA,
Under the quality system requirements of the
now enacted Medical Devices
Regulations, manufacturers of Class II medical devices must
have their devices manufactured in accordance with the
National Standard of Canada CAN/CSA-ISO 13488-98, Quality
Systems — Medical devices — Particular requirements for the
application of ISO 9002, as amended from time
to time, and
manufacturers of Classes III and IV medical devices must have
their devices designed and manufactured in accordance with the
National Standard of Canada CAN/CSA-ISO 13485-98, Quality
systems — Medical devices — Particular requirements for the
application of ISO 9001, as amended from time to time.
As currently written, the quality system requirements state
that a senior official of the manufacturer must submit, with
their application for a medical device licence, a written
attestation that their device is in compliance with the
applicable, above mentioned standard. The Medical Devices
Regulations further require that the attestation be based on
an audit by an organization that performs quality system
audits accredited by Health Canada (known as CMDCAS
recognised registrars.)
Several European Notified Bodies received their CMDCAS
accreditation last year. Click here to
see the latest registrars to have received CMDCAS recognition
or be delisted..
The
attestation quality system requirements will
apply to those manufacturers who will have device licences
prior to January 1, 2003, and will be required
by/after Nov. 1, 2003. For more information about ISO 13485/8,
click here.
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