TORONTO, June 10, 2011 /CNW/ - With the release on June 9, 2011 of the
Auditor General's Report on Health Canada's Medical Device Program,
MEDEC applauds the Office of the Auditor General (OAG) of Canada for
its ongoing efforts to ensure that the Medical Device Program meets its
obligations to provide timely access to medical technology and fulfills
its commitments to improve the program. MEDEC also commends the
efforts of Health Canada in attempting to meet the recommendations and
commitments of past audits. MEDEC endeavors to collaborate with Health
Canada on issues of mutual interest and has seen progress in our joint
The OAG report clearly shows that Health Canada is not fully meeting its
obligations in relation to medical devices. Defining clear targets and
actions would adequately address the nature of medical devices which
are substantially different to drugs or pharmaceutical products. There
is more work to be done and MEDEC looks forward to continuing to work
with Health Canada to resolve these issues.
The medical device industry has ongoing challenges with Health Canada's
performance on the time it takes to make decisions on applications for
medical devices. Our members see first-hand how the delays affect the
care provided by healthcare professionals to Canadians. While we are
aware of the challenges the Department has had in resourcing its
medical device program, we feel that there are other means to address
issues related to the delays which affect Canadians' access to
The OAG refers to one of these means - greater cooperation with foreign
regulatory bodies. The MEDEC position is that by expanding, and
accelerating international cooperation, delays in reviews can be
significantly reduced. For example, products that are already approved
and marketed in the United States or Europe should have an expedited
and streamlined process for Health Canada review and approval.
While the OAG reports that Health Canada has significantly expanded its
post-market activities, MEDEC noted that Health Canada still faces
challenges in meetings its requirements.
MEDEC supports the expanded post-market activity of Health Canada and
will look for ways to enhance our support.
MEDEC will continue to work with Health Canada to ensure patients in
Canada get timely access to safe, proven medical technologies that
improve health outcomes and improve the lives of Canadians.
MEDEC is the national association representing the medical technology
industry in Canada. Our members are committed to providing safe and
innovative medical technologies that enhance patient care and advance
patient outcomes. The medical technology industry in Canada employs
over 35,000 Canadians in close to 1,500 corporate facilities, and has
sales of nearly $7 billion per annum. We are committed to ensuring that
Canada has a strong and vibrant medical technology industry.
SOURCE MEDEC (Canada's Medical Device Technology Companies)
For further information:
416-620-1915, ext. 227