On November 8, 2025, Health Canada published proposed amendments to the medical device establishment licensing framework in the Canada Gazette, Part I. The consultation is open for stakeholder feedback until January 17, 2026.
If you hold, or are planning to apply for, a Medical Device Establishment Licence (MDEL), these proposed changes are worth reviewing closely. The proposal package is designed to reduce duplicated licensing, strengthen supply chain traceability, and remove ambiguity around “documented procedures” expectations during inspections.
- Current Medical Device Establishment Licence (MDEL) Role
- What Is Changing: Three Core Health Canada Proposals
- Timeline and Next Steps
- Considerations for Medical Device Manufacturers
- How to Submit Comments During the Canada Gazette Consultation
- Final Remarks
- FAQs
- What is the difference between an MDEL and a Medical Device Licence (MDL)?
- Who is required to hold an MDEL under the current framework?
- Why is Health Canada proposing changes to the MDEL requirements if an MDEL already exists?
- How will the proposed amendments affect foreign manufacturers and distributors?
- When would the proposed MDEL amendments take effect, and what should companies do now?
Current Medical Device Establishment Licence (MDEL) Role
What Is a Medical Device Establishment Licence (MDEL)?
In Canada, Health Canada regulates not only individual medical devices, but also the companies that bring those devices into the country and make them available for sale. The Medical Device Establishment Licence, commonly referred to as an MDEL, is the primary regulatory tool used to oversee these company-level activities.
An MDEL does not approve or authorize a specific medical device. Instead, it authorizes a company to carry out regulated activities, primarily the importation of medical devices into Canada and their sale or distribution within the Canadian market.
Who Is Required to Hold an MDEL in Canada?
In most cases, any company that imports or distributes medical devices in Canada is required to hold an MDEL, unless a specific regulatory exemption applies. This requirement generally applies to importers and distributors of all classes of medical devices, as well as to manufacturers of Class I medical devices when they import or distribute their own products in Canada.
Manufacturers of Class II, III, or IV medical devices are regulated differently. These manufacturers are required to hold an MDL for the device itself. Where the same company that holds an MDL also imports or distributes that licensed device in Canada, a separate MDEL is not required. In these cases, Health Canada relies on the device-level licensing framework to oversee those activities.
When an MDEL Is Required for Third-Party Importers or Distributors
Where a manufacturer holds a MDL but relies on a separate company to import or distribute the device in Canada, that second company is conducting establishment-level activities and must hold an active MDEL. In practical terms, the obligation to hold an MDEL follows the activity being performed, not the ownership of the device licence.
Ongoing Responsibilities of MDEL Holders
Holding an MDEL comes with ongoing compliance obligations. Establishment licences must be renewed on an annual basis, and licence holders are required to establish, implement, and maintain documented procedures to manage medical devices once they are on the market.
These procedures must address activities such as complaint handling, mandatory problem reporting to Health Canada, and the execution of product recalls. Together, these requirements support traceability across the supply chain and enable Health Canada to respond effectively when safety or quality concerns arise.
More about MDL and MDEL requirements in our previous article.
What Is Changing: Three Core Health Canada Proposals
At a high level, the proposed amendments do not introduce a new establishment licensing model. Rather, they are intended to resolve a long-standing misalignment between how the Medical Devices Regulations are written and how Health Canada has applied them in practice.
While establishment-level accountability already rests with the party importing or distributing medical devices in Canada, the current regulations have also required importers to verify that their upstream supplier holds an establishment licence, even where the Canadian importer already holds an MDEL. This has resulted in duplicative licensing for certain foreign distributors. The proposed amendments formalize a risk-based approach by removing this redundancy from the regulations themselves and by strengthening supply chain visibility through alternative regulatory controls.
As a result, Health Canada has proposed a targeted set of amendments designed to modernize the establishment licensing framework while maintaining appropriate regulatory oversight. These proposed changes are structured around three core principles:
Reducing duplicative establishment licensing by adopting a risk-based approach to foreign distributor oversight where a licensed Canadian importer or distributor is already accountable.
Strengthening supply chain visibility and traceability through mandatory submission and annual maintenance of medical device supplier information by all MDEL holders.
Clarifying and reinforcing post-market compliance expectations by making requirements for documented safety management procedures explicit within the Medical Devices Regulations.
First Core Proposal: A Risk-based Approach to Foreign Distributor Licensing
Health Canada is proposing to remove the requirement for Canadian MDEL holders, such as licensed importers, to source medical devices exclusively from foreign distributors that also hold an MDEL. In Health Canada’s view, where a Canadian importer already holds an MDEL and is responsible for managing compliance and post-market obligations, requiring the foreign distributor to hold a separate establishment licence does not provide additional health and safety benefit.
It is important to note that this change would not apply universally. Retailers and health care facilities that import medical devices without holding an MDEL would continue to be required to verify that the party they import from holds an MDEL. The proposed amendments are therefore targeted and risk based.
From a regulatory perspective, this approach is reflected in proposed amendments to subsection 44(4) of the Medical Devices Regulations, which would expand the circumstances under which an importer may import devices from a non-manufacturer when the importer itself holds an establishment licence.
In practical terms, licensed Canadian importers can expect reduced administrative burden when sourcing devices internationally, while some foreign distributors selling exclusively through licensed Canadian importers may no longer be required to maintain a standalone MDEL.
Second Core Proposal: Mandatory Submission of Supplier Information
Since February 2020, Health Canada has requested that MDEL applicants and holders voluntarily provide supplier information. However, participation has been inconsistent, which has limited Health Canada’s ability to trace medical devices through the supply chain when compliance or safety issues arise.
Under the proposed amendments, supplier information would become a regulatory requirement. MDEL applicants would be required to submit supplier information as part of their initial application, and MDEL holders would be required to review and update this information annually as part of the licence review process.
The proposed amendments would introduce new information requirements into section 45 of the Medical Devices Regulations, including the name and address of any person, other than the manufacturer, who sells a medical device to the establishment for the purposes of importation or distribution, as well as the classes of devices supplied by each such person.
Health Canada has been clear that this change is intended to support more targeted and efficient compliance and enforcement activities. Mandatory supplier information would maintain visibility over foreign distributors, even in cases where those distributors are no longer required to hold an MDEL, and would strengthen traceability across increasingly complex and globalized supply chains.
Third Core Proposal: Clear, Explicit Requirements to Establish, Implement, and Maintain Documented Procedures
Health Canada has identified recurring compliance issues during inspections related to documented procedures. In many cases, procedures were found to be missing, incomplete, outdated, or not fully implemented, despite establishments having attested that such procedures were in place.
To address this, the proposed amendments would make explicit the requirement for manufacturers, importers, and distributors to establish, implement, and maintain documented procedures for core safety management activities. These activities include the maintenance of distribution records, incident reporting and related reporting processes, handling, storage, delivery, installation, servicing of devices where applicable, corrective actions, and the timely provision of information linked to licensing and importer obligations.
By setting these expectations directly in the regulation, Health Canada also proposes to reduce the number of attestations required during the licensing process, improving clarity around regulatory obligations and reducing ambiguity during inspections.
For manufacturers of Class II, III, and IV medical devices, Health Canada does not anticipate incremental burden. These manufacturers are already required to maintain documented procedures as part of a quality management system aligned with ISO 13485:2016, and the proposed amendments are intended to reinforce, rather than expand, existing expectations.
Other Administrative Simplifications
In addition to the core amendments, Health Canada is proposing a targeted administrative simplification by removing the requirement for MDEL applicants and holders to identify the medical specialities associated with each manufacturer listed on their licence.
In the context of MDEL applications, medical specialities refer to broad clinical or therapeutic categories in which a manufacturer’s devices are used, such as cardiology, orthopaedics, dentistry, diagnostic imaging, or general surgery. This information has historically been collected to provide a high-level snapshot of the clinical areas linked to a manufacturer’s products.
Health Canada has indicated that medical speciality information is not used to assess device risk, support compliance or enforcement activities, or inform health and safety decision-making. Device risk classification and regulatory oversight are instead driven by factors such as intended use, invasiveness, and duration of contact, rather than the clinical discipline in which a device is used.
As a result, continuing to collect medical speciality information has created administrative effort for both industry and the regulator without providing meaningful regulatory value. Its removal is intended to streamline the establishment licensing process and allow regulatory oversight to focus on information that directly supports traceability, risk identification, and post-market surveillance.
Timeline and Next Steps
Consultation and Coming-into-force Timing
Health Canada published the proposed amendments in the Canada Gazette, Part I, formally opening the public consultation period. Stakeholders have until January 17, 2026, at 11:59 pm EST to submit comments.
If the amendments are finalized, they would come into force 180 days (six months) after registration, providing a defined transition period for regulated parties to update internal systems, documentation, and licensing processes to meet the new requirements.
The proposal also includes a transitional provision. Where an application for a MDEL has already been submitted but no decision has been issued at the time the amendments come into force, Health Canada would not issue the licence unless the applicant first submits the newly required supplier information. In practice, this means the supplier information requirement would apply not only to new applications, but also to applications that are already in the licensing queue at the time of implementation.
How to Prepare for Health Canada’s Proposed MDEL Amendments
Although the MDEL amendments are still at the proposal stage, there are several prudent steps regulated parties can take now to prepare.
Importers and distributors should begin by ensuring that their supplier information is complete, accurate, and readily reportable. This includes capturing the legal name and address of each supplier, along with the classes of medical devices supplied. This mirrors the proposed additions to section 45 of the Medical Devices Regulations and will reduce friction if and when the amendments are finalized.
It is also advisable to review documented procedures against operational practices. Health Canada’s inspection observations have consistently focused not only on whether procedures exist, but on whether they are current, comprehensive, and demonstrably implemented. Gaps between documented processes and real-world execution are likely to remain a focal point under the amended framework.
Lastly, companies sourcing from foreign distributors should review their upstream sourcing models. Where foreign suppliers currently hold an MDEL primarily to satisfy the existing verification requirement, contractual arrangements and onboarding expectations may shift under the proposed amendments.
Considerations for Medical Device Manufacturers
Manufacturers, particularly those of Class I medical devices, should confirm whether their activities trigger MDEL obligations, especially where importation or distribution activities extend beyond manufacturing alone. Health Canada’s guidance, including GUI-0016, provides useful examples of when an MDEL is required versus when an exemption applies.
Manufacturers should also ensure that post-market surveillance, distribution controls, and safety management procedures align with the explicit documented procedure requirements being proposed, even where these obligations already exist in practice under quality management system requirements.
How to Submit Comments During the Canada Gazette Consultation
Health Canada is encouraging all stakeholders to provide input through the Canada Gazette consultation process for the proposed amendments. Submissions made during the consultation period will inform the final regulatory text and implementation approach.
Final Remarks
Taken together, the proposed amendments reflect a targeted recalibration of the MDEL framework. The changes are intended to reduce duplicative licensing requirements that offer limited incremental risk mitigation, while enhancing Health Canada’s visibility into medical device supply chains through mandatory supplier information and more explicit, enforceable requirements for safety management procedures.
For regulated parties, the proposal does not introduce a fundamentally new compliance model. Rather, it clarifies regulatory accountability across the supply chain, strengthens traceability when safety or quality issues arise, and provides greater certainty around expectations during inspections. Collectively, these measures support more consistent regulatory oversight and closer alignment with international regulatory approaches, while maintaining a strong focus on protecting health and safety in Canada.
How SNI Can Support Your Medical Device Regulatory Strategy
Understanding and preparing for changes to the Medical Devices Regulations requires a practical, regulation-aligned approach. SNI supports medical device manufacturers, importers, and distributors with Canadian regulatory strategy, including MDEL and MDL licensing, renewals, exemption assessments, supplier and supply chain reviews, and post-market compliance planning.
Our team works with clients to translate regulatory requirements into clear, defensible compliance frameworks that align with Health Canada’s expectations. If you have questions about how the proposed MDEL amendments may affect your operations or would like support preparing for implementation, SNI’s regulatory team is available to assist.
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FAQs
What is the difference between an MDEL and a Medical Device Licence (MDL)?
An MDEL authorizes a company to import or distribute medical devices in Canada and governs establishment-level activities such as complaint handling, incident reporting, and recalls. A Medical Device Licence (MDL) authorizes the sale of a specific Class II, III, or IV medical device in Canada and applies to the device itself rather than the company’s activities.
Who is required to hold an MDEL under the current framework?
In general, any company that imports or distributes medical devices in Canada must hold an MDEL unless a regulatory exemption applies. This includes importers and distributors of all device classes, as well as manufacturers of Class I medical devices that import or distribute their own products. Manufacturers of Class II, III, or IV medical devices do not require an MDEL when importing or distributing their own licensed devices.
Why is Health Canada proposing changes to the MDEL requirements if an MDEL already exists?
While establishment-level accountability already rests with the party importing or distributing medical devices in Canada, the current regulations have also required importers to verify that their upstream supplier holds an establishment licence. This has resulted in duplicative licensing for some foreign distributors. The proposed amendments are intended to remove this redundancy, formalize Health Canada’s risk-based approach, and improve supply chain visibility through mandatory supplier information.
How will the proposed amendments affect foreign manufacturers and distributors?
Under the proposed changes, foreign distributors selling exclusively through licensed Canadian importers may no longer be required to hold an MDEL. Foreign manufacturers that do not directly import or distribute medical devices in Canada will continue to rely on Canadian MDEL holders for importation and distribution activities, while remaining responsible for applicable device-level licensing requirements.
When would the proposed MDEL amendments take effect, and what should companies do now?
If finalized, the proposed amendments would come into force 180 days after registration. Companies should begin reviewing their supplier lists, documented procedures, and importation models now to ensure they are prepared to meet the new requirements once implemented.
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