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

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Health Canada's Medical Devices Special Access Program (MDSAP) plays a key role in health technology management (HTM) by aiding technology selection, procurement, and innovation, not circumventing licensing.

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Area of Science:

  • Health Technology Management
  • Canadian Healthcare Policy
  • Medical Device Regulation

Background:

  • Understanding how new health technologies enter Canadian healthcare is crucial for a national Health Technology Management (HTM) Strategy.
  • Health Canada's Medical Devices Special Access Program (MDSAP) allows access to unlicensed devices but its use is not well-understood.

Purpose of the Study:

  • To clarify the circumstances and implications of MDSAP use in Canadian healthcare.
  • To identify the roles and issues associated with MDSAP within the context of HTM.

Main Methods:

  • A scoping literature review was conducted.
  • The review aimed to synthesize existing information on the MDSAP's function in healthcare.

Main Results:

  • Limited information was available on the MDSAP.
  • Three key roles emerged: arbiter in technology selection, a route for technology procurement, and a facilitator of health technology innovation.
  • No evidence was found that MDSAP is used to bypass licensing requirements.

Conclusions:

  • MDSAP facilitates access to needed medical devices, supporting desired patient outcomes and product commercialization.
  • The program is an integral part of the health technology management landscape in Canada.