The Medical Devices Special Access Program in Canada: A Scoping Study.

Healthc Policy

Director, Health Technology and Policy Unit, School of Public Health, University of Alberta, Edmonton, AB.

Published: February 2018

New health technologies enter Canadian healthcare organizations in various ways, and understanding them is essential to the development of a pan-Canadian Health Technology Management (HTM) Strategy, now a priority of governments across Canada. One way is through Health Canada's Medical Devices Special Access Program (MDSAP), which permits unlicensed devices to be obtained by healthcare professionals. However, the circumstances around and implications of the current use of this program are not clear. A scoping literature review was conducted to clarify these and identify important roles and issues related to the MDSAP. Limited information was found on the MDSAP. Nevertheless, three themes demonstrating the roles of the MDSAP in HTM emerged: arbiter in technology selection, a route to technology procurement and facilitator of health technology innovation. No information suggesting that MDSAP is used to circumvent licensing was found. Rather, it enables desired patient outcomes and product commercialization.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5863869PMC
http://dx.doi.org/10.12927/hcpol.2018.25398DOI Listing

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