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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. 


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).    

2022

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December 24, 2022 -  Regulations Amending the Products Containing Mercury Regulations

Canada Gazette, Part I, Volume 156, Number 52

On December 24th, 2022, the proposed Regulations amending the Products Containing Mercury Regulations (the proposed Amendments) were published in the Canada Gazette, Part I, for a 75-day comment period. 

The main objective of the proposed Amendments is to protect Canadians by lowering the risk of mercury releases into the environment from lamps in Canada. By meeting this objective, the proposed Amendments will also enable Canada to meet its obligations for mercury containing products under the Minamata Convention.

The text of the proposed Amendments along with the associated Regulatory Impact Analysis Statement are available on the Canadian Environmental Protection Act Registry.

If members would like DIAC to provide comments on these regulations, please provide your comments to info@diac.ca by Feb 28th

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Medtech Canada - BioTalent Canada

December 15, 2022 -  Intro to Regulatory in Software as a Medical Device (SaMD)

Courtesy of Medtech Canada here is a link to the recording, https://vimeo.com/782941734, and provided below are the slides from Yu-Wen Wang’s presentation, Intro to Regulatory in Software as a Medical Device (SaMD).

Click Here to view the presentation slides

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December 7, 2022 -  Regulations Amending the Pest Control Products Regulations (Applications and Imports): SOR/2022-241

Canada Gazette, Part II, Volume 156, Number 25

PEST CONTROL PRODUCTS ACT | P.C. 2022-1217 November 17, 2022

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health makes the annexed Regulations Amending the Pest Control Products Regulations (Applications and Imports) under section 67 of the Pest Control Products Act.

What DIAC Members Should Know:

Canada Gazette II publication for PMRA regulations bring Class I MDs into scope for PMRA requirements. 

Background: In April 2022, Canada’s PMRA (Pest Management Regulatory Agency) published their proposed amendments to the PCPR (Pest Control Products Regulations) in the Canada Gazette I, including adding the definition of treated articles and amending Section 2 of the regulations to prescribe treated articles as pest control products. This means that formulated products containing a preservative would be considered a treated article regulated as pesticides under the Pest Control Products Act.

Issue #1: This issue was first brought up in an Information Note in 2018 where the PMRA stated they were defining a treated article as a way of only codifying existing practice. CCSPA (Canadian Consumer Specialty Products Association) had raised the issue several times that this was not industry’s understanding of the definition, and it could not be enforced as it wasn’t defined in regulation. The PMRA responded by publishing the amendments that now contain this definition and have given 180 days from the publishing of Canada Gazette II for the coming into force of these regulations. This has not changed with the Gazette II publication even though issues were raised with the timing and corresponding data was provided.

Issue #2: In previous correspondence, there was listing of amendments including products covered under other acts including Food and Drugs Act, Feeds Act and Fertilizers Act. Wording in previous communication stated this would include ALL products regulated under the aforementioned acts, while this new publication in Canada Gazette II has removed this exemption for Class I Medical Devices.

Scope: Formulated or textile products treated with a preservative during the manufacturing stage, in order to protect the product and to extend its shelf-life, excluding products regulated under Food and Drugs Act, Feeds Act and Fertilizers Act (except Class I Medical Devices: wheelchairs, wound care, toothbrushes, compression stockings, splints, cervical braces, etc.)

Application:

Preservatives used in the manufacturing of treated articles within Canada must be registered with the PMRA.

Preservatives for products manufactured in foreign jurisdictions that are imported into Canada would be exempt from registration requirements and would instead be subject to the following authorization criteria:

  • Preservative must contain the same active ingredient that is registered with the PMRA for that specific use site at the same rate it is being used (attached list of actives)

UPDATE - December 22, 2022

Courtesy of Procter & Gamble Oral Health, click here to review a list of products that could be impacted by the new requirements detailed above.

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    September 21, 2022 -  Substances Search Tool Updated

    The Substances Search tool has been updated with information current as of Sept 12th, 2022. The list Human and Animal Pathogens on the Domestic Substances List has been replaced with a new list Living Organisms on the Domestic Substances List (including the human and animal pathogens). As well, the following lists now indicate which substances are living organisms:

    • New Substances Risk Assessment Summaries;
    • Domestic Substances List (DSL);
    • Ministerial Conditions; and
    • Significant New Activity (SNAc) Orders and Notices.

    Although care has been taken to ensure the accuracy of information contained in this search tool, should any inconsistencies be found, the official versions of the text of the legislation, regulations, instruments, or notices, for example on the Justice website and Canada Gazette publications, prevail.

    Click Here to access the Substances Search Tool

    For any questions, please do not hesitate to contact the Substances Management Information Line:

    Email: substances@ec.gc.ca | Telephone: 1-800-567-1999 (within Canada) or 819-938-3232 (outside of Canada)

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    September 15, 2022 -  Environment and Climate Change Canada issued its CMP Risk Management Publications Plan for October to December 2022

    Canada’s Chemicals Management Plan (CMP) program is sharing the following Publications Plan to inform stakeholders of risk management (RM) publications for the coming year. Please note that the targeted publication dates are subject to change. The program is providing stakeholders with a one-year overview of publications on a quarterly basis.

    Here are the publications that the program plans to publish in the next quarter:

    Risk Management Publications targeted for October to December 2022

    Proposed Regulations Amending the Products Containing Mercury Regulations*

    For more information, please refer to: Products Containing Mercury Regulations: proposed amendments  

    Environmental Performance Agreement for the Formulation of Chlorhexidine Products

    For more information, please refer to: Chlorhexidine and its salts

    Proposed Coal Mining Effluent Regulations under the Fisheries Act*

    For more information, please refer to: Proposed Coal Mining Effluent Regulations: overview

    Final Regulations Prohibiting the Manufacture and Import of Wheel Weights Containing Lead in Canada

    For more information, please refer to: Regulations Prohibiting the Manufacture and Import of Wheel Weights Containing Lead in Canada

    Notice of intent on the labelling of toxic substances in products, including toxic flame retardants

    Proposed Environmental Performance Agreement for the Refractory Ceramic Fibre Industry (renewal)*

    For more information, please refer to: Refractory ceramic fibre industry: environmental performance agreement overview

    * Stakeholders will be given the opportunity to file comments with respect to the proposed actions. 

    Here are the publications that the program plans to publish throughout the subsequent nine months: 

    Risk Management Publications targeted for January 2023 to September 2023

    Proposed Code of Practice for the Environmentally Sound Management of Chemical Substances in the Chemicals, Plastics and Rubber Sectors*

    Order to amend the Domestic Substances List (DSL) to apply the significant new activity (SNAc) provisions to 2-Ethylhexyl-2-ethylhexanoate

    Notice of intent to amend the Domestic Substances List (DSL) to apply the significant new activity (SNAc) provisions to Malachite Green*

    Proposed Code of Practice for Benzophenone*

    Proposed Environmental Performance Agreement to Reduce the Total Concentration or Quantity of Dinoseb in Industrial Effluents*

    Proposed Regulations that would prohibit the manufacture, import and sale of coal tar-based sealant products in Canada*

    Proposed Regulations Amending the PCB Regulations*

    Proposed Amendment to Guidelines for Reduction of Dyes Released from Pulp and Paper Mills to Add Certain Triarylmethanes*

    * Stakeholders will be given the opportunity to file comments with respect to the proposed actions. 

    Note: Information on Government of Canada regulations is available in the Forward Regulatory Plan (FRP), which is produced by the Treasury Board of Canada Secretariat every year on April 1. 

    For any questions, please do not hesitate to contact the Substances Management Information Line: 

    Email: substances@ec.gc.ca

    Telephone: 1-800-567-1999 (within Canada) or 819-938-3232 (outside of Canada) 

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    Medtech Canada - BioTalent Canada

    August 24, 2022 -  Medtech Canada

    Medtech Canada conducted a brief read of the Federal Environmental Quality Guideline for BPA (Canadian Environmental Protection Act, 1999 Federal Environmental Quality Guidelines Bisphenol A - Canada.ca) as well as review of the comments and changes.

    Based on their review, from all the recommendations made, the following changes were approved:

    Information & data updates Update the current FWQG with new information that was provided. Also, add 10 studies (including three marine studies) and remove five studies from the dataset. Upon scientific review, the 10 suggested studies were not included because they do not meet the criteria for developing this FEQG. Two of the five studies suggested for removal do meet the FEQG data acceptability criteria and were retained. Three studies were removed because they do not meet FEQG data acceptability criteria. As a result the final FEQG value is higher for water, sediment, and mammalian wildlife than that presented in the draft.
    Methodology Details regarding identification and classification of studies for inclusion or exclusion were requested.  Details regarding identification and classification of studies for inclusion or exclusion were added to the final FEQG. In particular, the methodology used when gathering toxicity data, and that Canadian Council of Ministers of the Environment (CCME) protocols for determining data acceptability were followed.
    Information & data updates Update the Federal Wildlife Dietary Guideline (FWiDG) with new values from recent research. Based on this new information, the endpoint for developing the FWiDG was changed to 5 mg/kg-bw/day. This value is supported by Environment & Climate Change Canada, Health Canada (2008) and by the United States Food and Drug Administration. This change resulted in a higher FWiDG for mammals than was presented in the draft.

    To learn more about the Federal Environmental Quality Guidelines, click here. 

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    July 25, 2022 -  The Government of Canada published Consultation paper: a proposed federal plastics registry for producers of plastic products

    The purpose of this consultation paper is to seek stakeholder input as the Government develops this registry. Partners, stakeholders and interested members of the public are invited to provide comments.

    Overview:

    The Government of Canada has committed to supporting provincial and territorial extended producer responsibility (EPR) efforts by establishing a federal plastics registry and requiring producers to report on plastics in the Canadian economy.

    A federal plastics registry would:

    • Support adoption of EPR rules in Canada that are consistent, comprehensive and transparent. 
    • Support the implementation and monitoring of other measures that are part of the Government’s zero plastic waste agenda, including recycled content requirements for plastic products.
    • Improve the efficiency and effectiveness of EPR as it is practised in Canada and increase value recovery rates, keeping plastics in the economy and out of the environment. 
    • Help achieve the goal of zero plastic waste, which could eliminate $500 million in costs, reduce greenhouse gas emissions by 1.8 megatonnes, and create 42,000 direct and indirect jobs.

    Written feedback to this consultation paper is requested by October 7, 2022.

      Click here to view and download the full consultation paper as a PDF

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      July 25, 2022 -  The Government of Canada published Consultation paper: Towards Canada-wide rules to strengthen recycling and composting of plastics through accurate labelling

      The Government of Canada has committed to introducing labelling rules that prohibit the use of the chasing-arrows symbol on plastic products unless 80 per cent of Canada’s recycling facilities accept, and have reliable end markets for, these products. In addition, the Department is seeking to address inaccurate biodegradability, degradability, and compostability claims for plastic products.

      This consultation paper is the first opportunity for stakeholders to provide input on how this commitment could be met. It outlines the Government’s current understanding of the issue and proposes potential approaches for establishing a labelling regime for recyclable and compostable plastics in Canada, focusing on plastic packaging and single-use items.

      Stakeholders and interested Canadians are invited to provide their feedback on anything raised in this paper. Comments received will help the Government understand the key issues, design an effective instrument to put the labelling rules in place, and develop an appropriate implementation approach.

      Executive Summary Highlights:
      • The Government of Canada has committed to introducing labelling rules that prohibit the use of the chasing-arrows symbol on plastic products unless 80 per cent of Canada’s recycling facilities accept, and have reliable end markets for, these products. 
      • The Government is proposing to introduce rules to regulate the use of terms such as “compostable”, “degradable” or “biodegradable” in the labelling of plastic packaging and single-use items.
      • The Government of Canada is proposing to introduce rules that would require producers to assess their packaging or single-use plastic item to determine whether it is recyclable. Producers would be required to select a compliance mechanism, such as a calculator, guideline or third-party labelling program. 
      • Accountability would rely on transparency and disclosure. Producers would be required, on request, to disclose to the Minister both the compliance mechanism chosen and the assessment of a particular package or single-use plastic item. 
      • For proposed compostability labelling rules, a producer would require third party certification of the plastic packaging or single-use item to a specified standard or standards for compostability.
      • The Government is also considering ways to promote and support compliance with labelling rules. 

      Written feedback to this consultation paper is requested by October 7, 2022.

        Click here to view and download the full consultation paper as a PDF

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        June 22, 2022 -  Environment and Climate Change Canada (ECCC) published the Single-use Plastics Prohibition Regulations  in the Canada Gazette, Part II, Volume 156, No. 13

        These regulations prohibit the manufacture, import, and sale of 6 categories of single-use plastics. These regulations also provide exemptions to accommodate people with disabilities.

        To assist stakeholders with the new regulations, Environment and Climate Change Canada published 2 guidance documents:

        Click here to learn more about the Government of Canada's actions aimed at tackling Plastic Pollution and how the proposed/enacted changes may affect you

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        COVID-19 and Mental Health (CMH) Initiative: About - CIHR

        July 2022 - The Ontario Government's regulatory change to "Healing Arts and Radiation Protection Act" Reg. 543 on shielding design methods will come into effect on July 1, 2022.

        The updated regulation can be found via the following link: O. Reg. 87/22: X-RAY SAFETY CODE (ontario.ca). 

        CLICK HERE to read the information sheet

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        February 21, 2022 - Quarterly update from MedTech Europe MedTech Europe Webinar, EU IVDR/MDR Implementation

        On February 21st, MedTech Europe presented its quarterly webinar for international associations on the EU IVD and Medical Devices Regulations (IVDR and MDR) and international matters on 21 February. 

        Click here to view and download the slide deck presented during the webinar.

        The recording of the presentation can be downloaded through the following link: EU IVDR/MDR Implementation - Quarterly update from MedTech Europe - YouTube

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        COVID-19 and Mental Health (CMH) Initiative: About - CIHR

        March 3, 2022 - Ontario Ministry of Health Update: Healing Arts Radiation Protection Act 

        CLICK HERE to read the update letter.

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        January 26, 2022 - Medtech Canada shared an update regarding an initiative by the International Medical Device Coalition 

        Medtech was among the contributors to a letter submitted to the ICAO Dangerous Goods Panel expressing concerns with proposed amendments to Air Transportation Regulations Affecting Shipments of Medical Devices.

        Medtech was pleased to report that the proposals were not supported at this time although a revised proposal is expected within the next 2 years. To review the Dangerous Goods Panel (DGP) Meeting report: DGP.28.WP.059.Full.en.pdf (icao.int)

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        2021

        November 13, 2021 - Canada Gazette, Part I, Volume 155, Number 46: Notice from Environment and Climate Change Canada (ECCC) Notice with respect to bisphenol A and BPA structural analogues and functional alternatives

        The Minister of the Environment requires any person described in sections 2 and 3 of this notice to provide the information required in sections 5 to 11 that may be in their possession, or to which they would reasonably be expected to have access. This information is to be provided no later than March 16, 2022. 

        Responses to this notice shall be submitted to the Minister of the Environment using the online reporting system available through Environment and Climate Change Canada’s Single Window.

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        November 10, 2021 - Environment and Climate Change Canada (ECCC) Key results from the 2019 reports under the Products Containing Mercury Regulations

        This report provides a summary of exempted essential products containing mercury that were imported or manufactured in Canada under the Products Containing Mercury Regulations. All information in the report is based on data submitted by organizations that imported or manufactured products containing mercury in Canada for the triennial reporting years 2016 and 2019. 

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        COVID-19 and Mental Health (CMH) Initiative: About - CIHR

        October 7, 2021 - Ontario Ministry of Health Consultation on Healing Arts and Radiation Protection Act (HARPA): Follow up Letter to Dental Suppliers and Testers 
        HARPA Follow-up Letter Dental Sector.pdf


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