Barrier to Entry: How Health Canada's Medical Device Single Audit Program Limits Patient Access to New Technology in Canada.

In this article, we look at the approval process for medical devices in Canada, and how the Medical Device Single Audit Program (MDSAP) has made it unfeasible for small manufactures to enter the Canadian market. Specifically, we explore how MDSAP has been a barrier in Canada for the entry of hypoglossal nerve stimulators (HGNS), a proven technology with a strong track record in other markets for the treatment of obstructive sleep apnea. This is ultimately preventing Canadian patients access to life-saving medical devices. We hope this commentary will shed light on this barrier and prompt Health Canada to explore other avenues for the approval of medical devices as is the case in other developed countries.