Australia-Canada TGA pact
October 22, 2010
THE Therapeutic Goods
Administration has today confirmed
a new Memorandum of
Understanding with Canadian
regulator Health Canada on
reciprocal recognition of quality
management system certificates for
medical device manufacturers.
The move means that medical
products manufactured in Canada
and Australia will not need
duplicate quality assessments, with
the TGA will recognising QMS
certificates issued in Canada, and
taking them into consideration as
part of an application for a
Conformity Assessment Certificate.
Similarly TGA certificates for
products made in Australia for
export to Canada will be recognised
by Health Canada.
Both regulators said the pact
would serve to enhance regulatory
cooperation between the TGA and
Health Canada, “and facilitate
timely access to new technologies.”
The move follows the completion
of a “rigorous confidence building
exercise” between the TGA and
Health Canada’s Products and
Foods Branch, which confirmed the
comparability of the two regulaory
systems in assessing a
manufacturer’s quality systems.
The move also encompasses New
Zealand manufacturers, who are
able to utilise the MoU to avoid the
need for duplicate assessments.
Australasian manufacturers that
wish to sell medical devices in
Canada must also meet the
Canadian product requirements
relating to medical devices.
Quality registrars can apply to be
recognised by the TGA, to allow
them to issue MoU certificates to
eligible Canadian manufacturers.
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