ArticleJournal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale
Barrier to Entry: How Health Canada's Medical Device Single Audit Program Limits Patient Access to New Technology in Canada.
Article in Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
3 authors.
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Abstract
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.