Precision Regulating - Health Canada's New Approach

The Regulatory Rapporteur 2025 first edition starts with changes at home, an exhaustive update on the Canadian Medical Devices Regulations SOR/98-282.

I. Precision Regulating

Last September at the IMDRF meeting in Seattle, Bruce Randall, Director General of the Medical Devices Directorate, introduced Health Canada's most recent amendments to the Food and Drugs Act in an effort to enable, precise, tailored regulatory solutions to emerging and ongoing issues.

He explained, how this new approach is expected to provide Health Canada with adaptable tools to address situations such as market disruptions, vulnerabilities and gaps that could impact availability of health products and food in Canada.

It would also give the Health Minister the authority to exempt a product or class of products from specific regulatory requirements, adding conditions as needed, the authority to rely on information or decisions from select regulatory authorities to specific regulatory requirements, and put in place supplementary rules for specific therapeutic products to protect against potential health risks or adverse effects.

The first series of amendments ensuing from this focused on modernizing the MDEL application, giving the Minister the ability to issue terms and conditions on an MDEL and on strengthening post-market activities.

II. Recall revamp

Key amendments include an updated definition of "recall" to includes recalls ordered by the Minister, establishing a regulatory framework for recalls of medical devices ordered by the Minister, clarifying industry's reporting and record-keeping obligations for recalls that they initiate and aligning the reporting of low-risk medical device recalls with that of international regulatory agencies.

 In Canada, recalls are classified into three Types:

The new Definition of “recall” now includes the corrective actions ordered by Health Canada, i.e. mandatory recalls. As opposed to only voluntary recalls initiated by manufacturers or other operators such as the distributors or importers.

The expected reporting timelines are now mandatory. Manufacturers must report their intention to conduct a Type I and type II medical devices recall within 24h.

Finally, and after a lot of push back from industry to align with global regulators practices, Health Canada no longer requires reporting Type III recalls. It is important to note that the requirements to notify end users and/or patients remain applicable.

These amendments came into effect on December 14, 2024 and the updated recall guidance was published on the 22nd of January 2025.

III. Modernization of the Medical Device Establishment Licence

Under the same project, Health Canada started a modernization of the medical device establishment licence (MDEL) application requirements to reflect current practices giving the Health Minister the ability to mitigate risks to health and safety through terms and conditions (T&Cs) and strategically target non-compliance.

T&Cs are obligations that the Minister may impose on the medical device licence holder to conduct an activity with respect to the medical device to which the authorization applies.

The main purpose of T&Cs is to optimize the benefits and manage risks and uncertainties associated with the medical device, including by collecting additional information after it has been authorized.

IV. Regulatory Enrolment process (REP)

This new platform is meant to facilitate a common intake process across business lines for the filing and processing of regulatory information related to Company, Dossier, Regulatory Activity and Transaction. It uses web-based templates and will replace the previous application forms (PDF, Word). It enables receipt of transactions via the Common Electronic Submission Gateway (CESG) and automated import of transaction and metadata into Health Canada’s internal systems.

The program opened to Medical Device manufacturers in July 2024 and will be mandatory 18 months after.

The following templates/forms are used to capture the necessary information related to company, dossier, transaction, and application respectively:

• Company (CO) Template;

• Dossier ID Request Form for Medical Devices;

• Regulatory Transaction (RT) Template;

• Application Information (AI) Template.

Collectively, these templates and forms are used in three distinct processes:

• Company Enrolment/amendment

• Dossier Identifier (ID) Request

• Filing a Regulatory Transaction (Application)

These templates replace the existing Class II/III/IV new licence application forms, Class II/III/IV licence amendment forms, all faxback (Minor Change) forms and private label licence application forms.

Scope and Application

Medical device regulatory activities pursuant to section 32 of the Medical Devices Regulations when submitted in Table of contents (ToC) format listed below are eligible to be filed via CESG using REP:

• Class II, III, IV licence applications

• Class II, III, IV licence amendments

• Class II, III, IV minor change amendments [Faxbacks] – including manufacturer name and/or address changes

• Class II, III, IV Private Label licence applications

• Class II, III, IV Private Label licence amendments Regulatory activities for the following are not in scope of REP at this time:

• Investigational Testing Application (ITA)

• Medical Device Establishment Licence (MDEL) Applications (i.e. Class I medical devices)

• Special Access Program (SAP) Applications

 

Important steps for enrolling in the REP program

Companies need to perform the following to ensure they are ready to send their REP transactions:

1. Obtain CESG account(s)

2. Obtain a Company ID (if needed) – CO enrolment/amendment process

3. Obtain a Dossier ID (if needed) – Dossier ID request form

4. Plan time to prepare the remaining REP templates – RT and AI templates

   
   

When sending transactions:

• Validate the transaction before sending via the CESG

• Verify the acknowledgement receipts (3) for successful delivery to Health Canada

Common Electronic Submission Gateway – What you need to know

In January 2013, Health Canada and the FDA entered into a Cooperative Research and Development Agreement. The agreement authorized both to work on a joint pilot to provide an electronic submissions gateway for industry with the aim to reduce the regulatory burden for health products.

REP's Company Enrolment/Amendment process

REP's dossier request process

REP's Regulatory Transaction (TR) Template process

V. Live market authorization timelines

Health Canada has now a page with quasi-live market authorization timelines.

The average market authorization time is the average time it takes between medical device application receipt, and licence issuance for the specific application type.

This period encompasses the entire review process, including any intervals during which additional information has been requested, company time to respond to the requests, and the subsequent evaluation of this additional data. 

This tool is very much appreciated given the considerable discrepancies between standard timelines committed by the Directorate and published on Health Canada's website and industry experience.

VI. Updates to Standards

Health Canada has updated the list of recognized standards for medical devices and the guidance on using standards to support compliance with the medical device regulations.

Most importantly, the updated list of Recognized standards has a new method of version recognition using standards listed without years and editions.

In my opinion, the time the Directorate is hoping to save by not having to update years and editions, will be spent arguing with manufacturers which versions they should be complying to, especially if a submission is made during the harmonization of a standard.

VII. Regulations Amending the Radiation Emitting Devices Regulations (Laser products)

Health Canada is now requiring compliance to IEC 60825-1- Safety of laser products: Equipment classification and requirements for Class I medical devices.

Specifically, Health Canada is requiring compliance to standards of Design, Construction and Functioning; and Information and Labelling for these products.

Class II, III and IV medical devices are exempt from this requirement.

VIII. Annual fee adjustments 

As with every year, regulators adjust their fees. Below are the new fees expected for 2025.

IX. Things to watch-out for

Catching-up on audits

Expect Health Canada to knock on your door, the Directorate is ramping up audits for MDEL holders who were not inspected due to the COVID pandemic.

Significant change

Health Canada's significant change guidance is still in draft. There was a lot of push back from the industry to keep the flowcharts, would be nice to see a final version published.

MDEL Requirements for Distributors

Health Canada may be removing the requirement for an MDEL for distributors outside of Canada who use an importer with an MDEL. This will certainly help make more medical devices available to Canadians.

X. Conclusion

Health Canada’s philosophy of post-market safety strengthening and agile regulations, could become a significant advantage particularly for Medical Device Software.

However, the close collaboration with the US FDA observed in the recent years may become a challenge with the new US administration.

The Directorate has, however, been quietly working on diversifying their collaboration and establishing new reliance initiatives with Australia’s TGA and UK’s MHRA, as well as strengthening MDSAP’s position globally, making Canada a significant voice in the international regulatory scene.

I am very curious to see how 2025 will play out for the medical device industry. Stay tuned for more updates on that.