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DIAC supports our members with regulatory information, advice and advocacy.

Visit this page regularly to ensure you are aware of regulatory matters applicable to your organization. Often the bulletins and updates posted here will also be shared in DIAC's Member e-Newsletter Bite-Sized News or Regulatory Matters.

Below are opportunities to participate in industry consultations. In some cases, please submit your feedback directly to the agency overseeing the consultation; in others, comments can be sent to DIAC for consolidation with MedTech

If you wish to share feedback with DIAC regarding any open consultations listed below, please email us at info@diac.ca. Your comments (anonymized to protect any sensitive information) will be shared with the Regulatory & Industry Affairs Committee (RIAC) and included in DIAC or Medtech's consolidated direct response to consultations. 

June 13, 2025 - PMRA Information Session Now Available

Slides from the June 13, 2025, PMRA webinar on the proposed amendment to the Pest Control Products Regulations are now available. The session focused on expanding the exemption for antimicrobial-treated Class I medical devices—such as manual toothbrushes, wheelchairs, and compression stockings—from the Pest Control Products Act. This change aligns oversight under the Food and Drugs Act and Medical Devices Regulations.

PMRA Information Slides (English)

PMRA Information Slides (French)

June 1, 2025 - Québec’s Bill 96: Final Phase Takes Effect

The final phase of Bill 96 – An Act respecting French, the official and common language of Québec comes into force on June 1, 2025. This sweeping legislation significantly amends the Charter of the French Language and other key statutes, introducing stricter requirements for language use in public signage, product packaging, and communications in Québec.

To help your organization prepare, FASKEN has published a dedicated resource page outlining the upcoming changes, potential risks, and practical steps for compliance. We encourage all members doing business in Québec to review this information.

Access the resource page here.



June 19, 2025 - Amendments to Products Containing Mercury Regulations

On June 19, 2025, amendments to the Products Containing Mercury Regulations officially came into force. These changes were first published in the Canada Gazette, Part II on June 19, 2024, under the Regulations Amending the Products Containing Mercury Regulations.

The amendments aim to reduce Canadians’ exposure to mercury by limiting its release into the environment. 

Key Highlights:

  • Effective June 19, 2025: Products with available mercury-free alternatives, or those no longer imported or manufactured in Canada, are now prohibited.
    ▸ Examples: Cold cathode tubing (e.g. neon signage), photographic paper and films, radiation and infrared detectors.
    ▸ Polyurethane catalysts will be prohibited as of December 31, 2025.

  • Phased prohibitions (2025–2030):
    Import, manufacture, and sale of the most common mercury-containing lamps will be gradually prohibited.
    ▸ Examples: Compact fluorescent lamps (CFLs), straight fluorescent tubes, and non-linear fluorescent lamps.

  • Special-purpose lamps remain exempt but require reporting under new categories.
    ▸ Examples: Lamps used for plant growth, disinfection, water treatment, or projectors.

  • Administrative clarifications include harmonized reporting deadlines with the U.S. Environmental Protection Agency (EPA).
    ▸ Next reporting deadlines:
    — March 31, 2026 (for 2025 data)
    — March 31, 2028 (for 2027 data)

Reporting Reminder:
If your organization imports or manufactures exempted or permitted mercury-containing products in 2025, you must submit a report by March 31, 2026 using Environment and Climate Change Canada’s online reporting system.

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January 31, 2025 - ECCC Webinar Recap: Federal Plastics Registry Reporting

On January 31, 2025, Environment and Climate Change Canada (ECCC) hosted its second webinar on the Federal Plastics Registry reporting portal. The session provided an overview of key features, testing processes, and a Q&A opportunity.

Key Takeaways

  • Training Documents: Five new guides are available to assist with login, registration, organization setup, system navigation, support requests, and reporting.
  • Testing Activities: Participants are testing organization registration, report submission, editing, and support requests.
  • Feedback Survey: Open until February 28, 2025 via MS Forms.
  • Bug Reporting: Issues should be reported with details to the designated ECCC inbox.
  • Phase 1 Reporting Scope: Focuses on plastic products and packaging imported, manufactured, and placed on the Canadian market for the residential waste stream.
  • Bulk Upload Feature: Expected in 2025, with no confirmed release date.
  • Electronics Reporting: Fixed factor methods and a draft calculator were shared for stakeholder review.
  • Plastic Resin Content: Suppliers outside Canada cannot report directly; responsibility falls on the company placing the product on the market.
  • Foreign Supplier Letters: Available in English, French, and Spanish, with additional translations under consideration.
  • Supporting Documents: The platform allows attaching PDFs or Excel files for context in reporting.
  • Exemptions & Clarifications:
    • Food packaging for business-to-business transactions is excluded from 2025 reporting.
    • Companies with no reporting obligations in Phase 1 are not required to submit administrative data.
    • Accessories for electronics must be reported.
    • 2025 reporting covers data from 2024 (January 1 – December 31).
    • B2B transactions are excluded from Phase 1.
    • New vehicle plastics removed at dealerships are not considered residential waste and are exempt.
    • EPS boxes and plastic bags should be categorized correctly to avoid duplication.
    • Parent vs. subsidiary reporting should align with provincial and territorial EPR structures.
    • Concerns about data duplication are being addressed in guidance documents.
    • Retailer obligations depend on producer definitions (brand owner, importer, or retailer).

Additional Support - Access training materials and resources:

Regulatory Services Platform (RSP) Webinar Presentation - ENGLISH 

Federal Plastics Registry User Guides:



Industry Consultations

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 December 12, 2024 - Review of Draft Guidance - Complying with the Unique Device Identification Regulations for Medical Devices

The Therapeutic Goods Administration (TGA) is seeking feedback on a new guidance document being drafted for the Australian UDI system: ‘Complying with the Unique Device Identification regulations for medical devices.’  

This guidance helps sponsors and manufacturers of medical devices understand their regulatory obligations under therapeutic goods legislation. 

Specifically, the document covers:

  • Medical devices and in vitro diagnostic (IVD) medical devices included in Unique Device Identification (UDI) regulations
  • Labelling requirements
  • Data submission requirements
  • Specific device requirements.

This document outlines the processes to get and apply a UDI, and submit and maintain UDI data in the Australian UDI Database (AusUDID). 

You can find the document, and provide your comments via our survey, here: Review of draft guidance - Complying with the Unique Device Identification regulations for medical devices - Therapeutic Goods Administration - Citizen Space

Consultation closes on January 15, 2025



Updates

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July, 2025 - Health Canada Addresses High Denial Rates in CDCP Claims

Nearly half of requests for complex dental treatment coverage under the Canadian Dental Care Plan are being denied, according to Health Canada.

In an exclusive interview with Canadian Affairs, Lindy Vanamburg, director general of the Oral Health Branch at Health Canada, said 49% of claims for complex dental care were denied between Nov. 1 and June 20, 2025. For details, click here. 

December 18, 2024 - Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing)

These amendments to the Food and Drug Regulations and Medical Devices Regulations continue to advance Health Canada’s modernization agenda by making Canada’s science-based regulatory system more agile and internationally aligned. In relation to medical devices, the amendments expand the scope of use of terms and conditions imposed or amended on class II to IV medical device licenses. 

The Agile Licensing Regulations have various coming into force dates for the different components. The amendments to the Medical Devices Regulations will come into force on January 1, 2026.   

Guidance on terms and conditions for class II to IV medical devices is also published. It outlines the amended regulatory authorities and provides guidance to medical device license holders and Health Canada staff on the use of medical device terms and conditions. This guidance will come into effect when the regulations come into force on January 1, 2026. 

For more details you can contact mddpolicy-politiquesdim@hc-sc.gc.ca. 

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Medtech Canada - BioTalent Canada

December 6, 2024 - Medtech Canada members feedback on Notice of intent — Consultation on modernizing the medical device establishment licensing framework (Phase II)

Click here to see feed back sent to Health Canada.

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October 22, 2024 – 2024 Oral Health Surveillance Report  

CDC released the 2024 Oral Health Surveillance Report: Dental Caries, Tooth Retention, and Edentulism, United States, 2017–March 2020. This surveillance report uses the National Health and Nutrition Examination Survey to provide national estimates for the prevalence and severity of dental caries in primary and permanent teeth for those 2 years or older and for tooth retention and edentulism in adults 20 years or older. Click here to access the report. 



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