{"id":34891,"date":"2025-11-25T14:44:24","date_gmt":"2025-11-25T13:44:24","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34891"},"modified":"2025-11-25T15:48:46","modified_gmt":"2025-11-25T14:48:46","slug":"health-canada-launches-phase-ii-consultation-to-modernize-medical-device-establishment-licences-mdel","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/11\/25\/health-canada-launches-phase-ii-consultation-to-modernize-medical-device-establishment-licences-mdel\/","title":{"rendered":"Health Canada Launches Phase II Consultation to Modernize Medical Device Establishment Licences (MDEL)"},"content":{"rendered":"

Translated with AI<\/em><\/strong><\/p>\n

On November 8, 2025, Health Canada (HC) launched a public consultation<\/strong><\/a> on the proposed modernization of the<\/strong> Medical Device Establishment Licences (MDEL)<\/strong>, which authorize the commercialization of medical devices.<\/p>\n

In anticipation of the imminent changes in the Second Phase<\/strong> of amendments to the Medical Devices Regulations<\/strong> and in order to increase predictability and transparency for the industry, Health Canada seeks to gather stakeholder opinions.<\/p>\n

This initiative follows the First Phase of amendments, which resulted in the publication of regulations in the Canada Gazette, Part II<\/em> (<\/a>June 17, 2024), effective December 14, 2024. Furthermore, it is part of Health Canada’s Forward Regulatory Plan 2024-2026<\/strong>, which defines strategic reform interventions to make the regulatory system more effective and streamlined.<\/p>\n

The consultation is open to all stakeholders and will remain available until January 17, 2026<\/strong> (Eastern Standard Time \u2013 EST). Health Canada will take the input gathered during this process into consideration for the final publication of the documents.<\/p>\n

Objectives<\/strong><\/h3>\n

The proposed amendment focuses on three key points, explicitly indicated by Health Canada:<\/p>\n

    \n
  1. Remove the requirement for Foreign Distributors<\/strong> to hold an MDEL, provided they sell their medical devices exclusively through Canadian distributors<\/strong> that hold a valid MDEL.
    \nThis change is supported by a Health Canada analysis estimating benefits for foreign distributors of $2.3 million CAD (in present value) over ten years.<\/li>\n
  2. Clarify the obligation for MDEL holders to establish, implement, and maintain documented procedures<\/strong> for all regulated activities.<\/li>\n
  3. Traceability:<\/strong> Require all MDEL applicants and licence holders to provide a list of persons (suppliers)<\/strong> who sell medical devices in Canada, with an obligation to keep it updated.<\/li>\n<\/ol>\n

    Guidance Documents Subject to Revision<\/strong><\/h3>\n

    Health Canada is also soliciting opinions on revisions to the following guidance documents and forms, which are integral to the MDEL system:<\/p>\n