{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T04:12:53Z","timestamp":1788581573154,"version":"build-2803163510"},"reference-count":10,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Otolaryngology - Head &amp; Neck Surgery"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:p>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.<\/jats:p>","DOI":"10.1177\/19160216261472799","type":"journal-article","created":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T06:58:25Z","timestamp":1788332305000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Barrier to Entry: How Health Canada\u2019s Medical Device Single Audit Program Limits Patient Access to New Technology in Canada"],"prefix":"10.1177","volume":"55","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-1437-1236","authenticated-orcid":false,"given":"Andrew","family":"Kokavec","sequence":"first","affiliation":[{"name":"Department of Otolaryngology\u2014Head and Neck Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tina","family":"Meisami","sequence":"additional","affiliation":[{"name":"Surgical and Dental Sleep Medicine, University Health Network, Toronto, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0258-3142","authenticated-orcid":false,"given":"Brian W.","family":"Rotenberg","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2014Head and Neck Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,9,1]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.17269\/s41997-024-00911-w"},{"issue":"3","key":"e_1_3_2_3_2","first-page":"170","article-title":"Factors affecting patients\u2019 adherence to continuous positive airway pressure therapy for obstructive sleep apnea disorder: a multi-method approach","volume":"45","author":"Aalaei S","year":"2020","unstructured":"Aalaei S, Rezaeitalab F, Tabesh H, et al. Factors affecting patients\u2019 adherence to continuous positive airway pressure therapy for obstructive sleep apnea disorder: a multi-method approach. Iran J Med Sci. 2020;45(3):170-178.","journal-title":"Iran J Med Sci"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12890-023-02613-z"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1007\/s13311-021-01012-x"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.rmed.2024.107826"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11325-019-01923-2"},{"key":"e_1_3_2_8_2","unstructured":"Health Canada. Medical Device Single Audit Program (MDSAP). Government of Canada. Accessed February 18 2026. https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/activities\/international\/transition-medical-device-single-audit-program.html"},{"key":"e_1_3_2_9_2","unstructured":"Emergo by UL. The Pathway to MDSAP: Assessing the Medical Device Single Audit Program. White paper. Published 2024. Accessed February 18 2026. https:\/\/www.emergobyul.com\/sites\/default\/files\/2024-03\/Pathway-to-MDSAP-Whitepaper.pdf"},{"key":"e_1_3_2_10_2","unstructured":"Gottlieb M White L. Review of recent regulatory amendments in Australia: international harmonization and reliance. Emergo by UL. Published 2024. Accessed February 18 2026. https:\/\/www.emergobyul.com\/news\/review-recent-regulatory-amendments-australia-international-harmonization-and-reliance"},{"key":"e_1_3_2_11_2","unstructured":"Health Canada. Health Canada\u2019s special access programs: request access to a medical device. Accessed April 28 2026. https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/special-access\/medical-devices.html"}],"container-title":["Journal of Otolaryngology - Head &amp; Neck Surgery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/19160216261472799","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/19160216261472799","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/19160216261472799","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T03:47:02Z","timestamp":1788580022000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/19160216261472799"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7]]},"references-count":10,"alternative-id":["10.1177\/19160216261472799"],"URL":"https:\/\/doi.org\/10.1177\/19160216261472799","relation":{},"ISSN":["1916-0216","1916-0216"],"issn-type":[{"value":"1916-0216","type":"print"},{"value":"1916-0216","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7]]},"article-number":"19160216261472799"}}