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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.



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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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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Medtech Canada - BioTalent Canada

November 21, 2023 -  Medtech Canada requesting members continue to provide feedback around Pre-Market concerns

Medtech Canada invites feedback from members regarding challenges you may have encountered during Health Canada licencing.

Share your feedback by responding to this survey:

https://forms.office.com/r/pBDmJsbSUm

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November 12, 2023 -  International Civil Aviation Organization (ICAO) Proposed Amendments to Air Transportation Regulations Affecting Shipments of Medical Devices

Medtech Canada, alongside other various International Associations such as Advamed and Medtech Europe, have submitted a Joint Association letter to the ICAO Dangerous Goods Panel Chairman.

This letter expresses the associations joint concerns with the proposed regulations on the transport of dangerous goods aboard aircraft which is being considered at the International Civil Aviation Organization (ICAO) Dangerous Goods Panel on November 13th, 2023.

These concerns are related to proposals impacting international air shipments of medical devices containing batteries and their significant impact on patient Care, operational, and cost implications for the medical industry.

Subsequently, on November 13th, a meeting took place at which feedback was provided on these critical concerns. A summary of the feedback is provided below, courtesy of Medtech Canada:

Update on Lithium Battery Transport Issue

The International Civil Aviation Organization (ICAO) Dangerous Good Panel’s (DGP) Energy Storage Device Working Group (WG) met on November 9th and 10th in Montreal to consider two key lithium ion battery-related air transport issues: whether lithium ion batteries packed with equipment, and lithium ion batteries contained in equipment, should be subject to a 30% state of charge (SOC) limit when shipped by air. The following report is based on George Kerchner’s participation in the WG meeting as an industry representative of the Portable Rechargeable Battery Association (PRBA). MDTC was not permitted to directly participate in the WG unfortunately, but we work very closely with PRBA and they are a strong advocate for medical device considerations at ICAO.

Lithium ion Batteries Packed with Equipment

As expected, the WG agreed to support a 30% SOC limit on lithium ion batteries packed with equipment shipped in accordance with Packing Instruction 966 of the ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO TI). They also agreed that lithium ion batteries with a Watt-hour rating not exceeding 2.7 Wh should be excepted from this SOC limit. If the batteries packed with equipment are offered for transport at a SOC exceeding 30%, they would need to be shipped as fully regulated, Class 9 dangerous goods under an approval issued by the State of Origin and the State of the Operator.

Lithium ion Batteries Contained in Equipment

The WG could not reach a consensus on whether lithium ion batteries contained in equipment should be subject to a 30% SOC limit. In fact, the majority of the WG members did not support a SOC limit on lithium ion batteries contained in equipment. The WG did agree to include language in Packing Instruction 967 of the ICAO TI that states lithium ion batteries contained in equipment “should” not exceed 30% SOC. Use of “should” implies the SOC limit would become more of a recommendation rather than a mandatory regulatory requirement.

To further address the safe transport of lithium ion and lithium metal batteries packed with and contained in equipment, the WG agreed to include concerning language in Packing Instructions 966, 967, 969, and 970 of the ICAO TI requiring packages containing these products to be “capable” of passing a 3 meter stack drop test to ensure battery integrity and limit fire risk. MDTC is opposed to this requirement which does not have sufficient data to warrant such a change that would be difficult to administer and would have significant impact on millions of devices shipped annually.

Medical Devices Containing Lithium ion Batteries

Thanks to the international device trade association letter and other advocacy efforts, an exemption from the SOC limits for lithium ion battery-powered medical devices was a major topic of discussion. There was recognition by some members of the WG that such an exemption is warranted in certain situations, but the language providing an exemption has not yet been developed for consideration this week by the DGP.

The WG meeting was the first step in the ICAO dangerous goods process to finalize changes for the 2025-2026 Edition of the ICAO TI. The DGP is meeting this week in Montreal and all the lithium battery-related issues will be addressed on Wednesday, November 15th. After the DGP completes its work, the ICAO Air Navigation Commission (ANC) must approve the decisions reached by the DGP. The final changes to the ICAO TI would be scheduled to take effect at the international level starting January 1, 2025. However, it is likely that the WG is supportive of adding a one-year transition to January 1, 2026 before the new requirements take effect.

Thank you for all of your extraordinary advocacy efforts on this critical issue. While a recommendation for 30% SOC is preferable to a requirement, should ICAO accept the WG recommendation, much work will remain to be done to secure a medical device carve-out for likely future consideration of additional restrictions for batteries contained in equipment shipped via air. 

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Medtech Canada - BioTalent Canada

November 1, 2023 -  Medtech Canada Risk Management Presentation

Medtech Canada has shared slides from a recent webinar on safety risk management for medical devices. The November 1st webinar was presented by Bijan Elahi, Technical Fellow, Corp. Advisor (Medtronic) and founder of MedTech Safety, Inc.

View & Download the Presentation Slides
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Medtech Canada - BioTalent Canada

October 6, 2023 -  Medtech Canada MDSAP Survey

Medtech Canada is planning to attend the next MDSAP meeting in Brazil in order to represent the Canadian’s industry experience around MDSAP. This is the first opportunity we have had of this nature and we are very excited!

We recently learned that the regulators and registrars are seeking from us (and other countries industry representatives) a brief presentation around MDSAP and its impact on industry (positive / negative / suggestions).

We request that you complete this survey as soon as possible so that we may use the feedback in our presentation.

https://forms.office.com/r/YLWQE9w7dv

DEADLINE to provide your feedback is October 13th, 2023

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European Association of Authorised Representatives (EAAR)

October 2, 2023 - The EAAR has today announced that its 8th Annual Conference on Medical Device Regulations will take place February 26-27, 2024 in Brussels, Belgium at the elegant Sheraton Brussels Airport Hotel

This distinguished educational conference is an inclusive platform for all stakeholders across the medical and IVD medical devices landscape in Europe. With a dedicated focus on the challenges faced by manufacturers and other stakeholders in embracing the EU MDR and IVDR, the event holds promise for all attendees, irrespective of their diverse backgrounds.

This occasion invites you to delve into the depths of European regulations, fostering insightful discussions on pivotal facets of these ever-evolving regulatory frameworks. Spanning topics from the divergence in national implementation of the regulations across Europe to cutting-edge regulatory topics concerning AI, clinical evaluation, UDI, post-market surveillance, and technical documentation, the Conference offers an all-encompassing journey. Covering the European Union, United Kingdom, and Switzerland, the event is poised to unravel a myriad of subjects that are of paramount importance.

The RMD Conference promises to be a momentous juncture for combining diverse actors and subjects within the compliance landscape. EU officials, manufacturers, competent authorities, notified bodies, and business associations will converge, igniting a collective dialogue that holds the potential to shape the future of the industry.

Learn More

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Global Medical Technology Alliance (GMTA)

June 6, 2023 - The Global Medical Technology Alliance (GMTA) has recently published a paper titled ‘The Need to Advance Global Convergence and Regulatory Reliance to Accelerate Access to Medical Technology.’

You are invited to read the paper on the GMTA website and refer to it when engaging with regulators and stakeholders on topics related to regulatory reliance and convergence.

From the Executive Summary:

The medical technology industry supports a strong regulatory system that ensures the safety and effectiveness of devices and promotes patients’ timely access to medical technologies. Regulations should be clear, consistent, least burdensome, foster efficiency and support innovation and be convergent to international best practices and standards. Implementing global convergence and regulatory reliance as a way of advancing “smart regulation” will:

  • Conserve and optimize the use of limited regulatory resources, elevate regulation to one high standard and accelerate access to safe, high-quality, effective, and innovative medical technologies to benefit patients, caregivers, and healthcare providers.
  • Facilitate an environment conducive to the growth of the medical technology sector, enhancing innovation and providing knowledge-based jobs.
  • Enhance global health equity through the acceleration of global access to safe, effective and innovative medical technologies.

To achieve this, GMTA outlines core tenets it recommends, and its members commit to carrying through to each jurisdiction. 

Click Here to read the full paper.

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DEPARTMENT OF THE ENVIRONMENT & DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

May 20, 2023 -  Publication of the draft state of per- and polyfluoroalkyl substances (PFAS) report (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)

Canada Gazette, Part I, Volume 157, Number 20

The Government of Canada has developed a draft state of PFAS report pursuant to paragraphs 68(b) and (c) of the Act and an executive summary of the draft report prepared on the class of PFASs is annexed. It is proposed to conclude that the class of PFASs meets one or more criteria set out in section 64 of the Act. As such, notice is given that the Minister of the Environment and the Minister of Health (the ministers) propose to recommend to Her Excellency the Governor in Council that the class of PFASs be added to Schedule 1 to the Act.

The ministers have released a risk management scope document for the class of PFASs to initiate discussions with stakeholders on the development of risk management options.

Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the considerations in the report. More information regarding the considerations may be obtained from the Canada.ca (Chemical substances) website. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by email to substances@ec.gc.ca or by using the online reporting system available through Environment and Climate Change Canada’s Single Window.

If members would like DIAC to provide comments on these regulations on their behalf, please provide your comments to info@diac.ca by July 7, 2023.  


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Save the Date: Canada’s Regulatory & Quality Medtech Conference June 28 & 29, 2023 presented by Medtech Canada 

 
Canada’s Regulatory & Quality Medtech Conference 2023 presented by Medtech Canada is the “Go To” regulatory & quality conference for the medical technology industry. Attendees will hear from and be able to engage with Health Canada and other stakeholders in a dialoguing and networking environment. To offer timely content, the Conference is taking place virtually on June 28 & 29, 2023. In addition, there will be an interactive bonus session with Health Canada Division Heads, who will provide tips on how to improve submissions.

Dates:

  • June 28 & 29, 2023*

*The interactive session will be finalized shortly and at this time is scheduled to run the week prior to the conference

What to expect from the Virtual Conference and a nod to a 2024 Face-to-Face meeting 

Your time is valuable!  Medtech Canada’s Education & Training Committee is working hard to ensure the most relevant topics are brought forward during this conference and would like to thank all of those that participated in providing their feedback in the survey that was sent out earlier this year.  

Based on the survey results, 2023 will continue to be a Virtual format. We appreciate that there was a healthy request for a face-to-face conference and are therefore aiming for a 2024 conference in Ottawa, as was done in prior years.  

Below are just some of the features of Canada’s Regulatory & Quality Medtech Conference:  

Multiple Networking Opportunities 

  • Book virtual meetings  
  • Chat with Health Canada 
  • Ask questions in advance and live  
Connect with colleagues – the most memorable moments from Canada’s Regulatory Medtech Conference in past years has been spending time with each other, connecting with people we haven’t seen in a while. Although meeting virtually will never replace an in-person connection, there will be many ways to link up during the Virtual Regulatory Medtech Conference.  

Flexibility – There will be lots of opportunities to interact with speakers and colleagues during the live virtual sessions; but if you can’t make it – don’t worry! It can be difficult to set aside hours for a virtual event, that’s why Medtech Canada is recording all live sessions. Sessions can be viewed at a time that fits best with your schedule (Note: Recordings of live sessions will be available to watch within a week after the live virtual session).    

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