Navigating the new era of Canadian medical device regulations: What MDEL holders need to know

The regulatory landscape for medical devices in Canada has undergone significant changes in recent years, ushering in a new era of compliance and operational updates for Medical Device Establishment Licence (MDEL) holders. These changes, introduced through the Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing): SOR/2024-136, came into effect on December 14, 2024. If you’re an importer or distributor holding an MDEL, understanding and adapting to these amendments is critical to maintaining compliance and ensuring the safety of the products you handle. Let’s explore the journey of these regulatory updates and their implications for your business.

A Timeline of Change

The journey to these amendments began in early 2023, when stakeholders were invited to review and comment on the proposed changes published in Canada Gazette, Part I. Following this, consultations were held in early 2024 to refine the guidance documents (Medical devices recall guide (GUI-0054) and Guidance on MDEL (GUI-0016)) that interpret and support the amendments. The finalized regulations were published in Canada Gazette, Part II on July 3, 2024, and officially came into force on December 14, 2024, providing the industry with 180 days to prepare for the updates.

For further background information, review the Regulatory Impact Analysis Statement within the amendment.

Key Updates to Medical Device Recalls

One of the most significant areas of change lies in the updated framework for medical device recalls. These updates aim to enhance clarity, streamline reporting, and strengthen Health Canada’s ability to manage recalls effectively. Here are the highlights:

Updating definition of "recall": The definition now also includes recalls ordered directly by the Minister of Health.
New reporting framework: A new section (65.2) has been introduced, outlining the requirements for reporting recalls ordered by the Minister.
Removing low-risk recall reporting: Reporting requirements for low-risk (Type III) recalls initiated by industry have been removed, reducing administrative burden.
Clarified industry obligations: Obligations for recalls initiated by industry are now explicitly stated in the Canadian MDR, including the requirement for 24-hour initial recall notifications.
Record-keeping obligations: Clearer guidelines have been provided for maintaining records and timelines for both industry-initiated recalls and those ordered by the Minister.

Modernizing medical device establishment licences (MDEL)

For MDEL holders, the amendments bring modernization and new tools to help ensure compliance and mitigate risks. Key updates include:

Application modernization: Application requirements now reflect current practices, such as providing comprehensive contact information and details on any previous business names (to allow Health Canada to examine applicant’s compliance history).
Terms and conditions for MDELs: The Minister now has the authority to impose specific terms and conditions on MDELs to address health and safety risks or non-compliance strategically.

Updated guidance and forms

With the regulatory amendments in place, Health Canada has also updated several key guidance documents and forms to align with the new requirements. Here’s what you need to know:

Recall guidance and forms

Guide to recall of medical devices (GUI-0054): A new webpage version became effective on December 14, 2024, replacing the previous version from 2016. A PDF version followed on July 22, 2025.
Medical device recall reporting forms (Initial: FRM-0360A and Final:FRM-0360B): These forms, introduced on May 8, 2025, include significant updates, such as additional shortage information fields, which is outside the reporting requirements within section 64 and 65 of the Medical Devices Regulations. While their use remains optional, revised versions are expected in the future to clarify optional fields.

MDEL guidance and policies

Guidance on medical device establishment licensing (GUI-0016): The updated version became effective on December 14, 2024, replacing the 2023 version.
Medical Device Establishment Licence Application Instructions and Form (FRM-0292): Updated on July 24, 2024, with further modifications on February 26, 2025.
New MDEL policy – Terms and conditions (POL-0156): Introduced on December 14, 2024, this policy provides a framework for the new terms and conditions authority.

Compliance and enforcement guidance

Guidance on medical device compliance and enforcement (GUI-0073): Updated on December 14, 2024, with further modifications in April 2025.
Risk classification guide for inspections (GUI-0079): Issued on November 21, 2025.
How Health Canada Inspects Medical Device Establishments (formerly GUI-0064): this guidance was updated on December 24, 2025.

Notably, the recall policy for health products (POL-0016) (August 15, 2019 version) has not been updated yet.

What this means for MDEL holders

These amendments represent a significant shift in the regulatory environment for MDEL holders. To remain compliant, it is essential to:

Update your procedures: Ensure your recall and MDEL maintenance procedures reflect the new requirements.
Revise your reference library: Incorporate the updated guidance documents and forms into your regulatory resources.
Stay proactive: Monitor Health Canada’s updates for future revisions to guidance documents and forms.

By staying informed and proactive, MDEL holders can navigate these regulatory changes with confidence, helping to ensure compliance and safeguarding public health.

Connect with our regulatory team for more information and assistance.

The information provided in this piece does not constitute legal or medical advice. Innomar Strategies Inc. and its parent Cencora, Inc. strongly encourage the audience to review available information related to the topics discussed to rely on their own experience and expertise in making decisions related thereto. Further, the contents of this piece are owned by Innomar Strategies, and reproduction is not permitted without the consent of Innomar Strategies.

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