Regulatory Bulletins, Consultations & Updates

Not including Health Canada - CLICK HERE to visit Health Canada Page

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.

Opportunities to participate or provide feedback are highlighted in yellow below. In some cases, your feedback should go directly to the agency conducting the consultation, while in others, comments may be submitted 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 Subject Matter Committee (RSMC) and included in DIAC or MedTech's consolidated direct response to consultations. 

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

Canada Gazette, Part I, Volume 157, Number 20

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  

2022

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)

• Preservative does not exceed the quantity necessary to preserve the article and is found in the Class II or Class III products listed under the List of Permitted Food Additives.

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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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.

• 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

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:

• Single-use Plastics Prohibition Regulations – Guidance for selecting alternatives, developed to help businesses and other organizations make decisions on alternative products or systems that prevent pollution and help Canada transition to a circular economy
• Single-use Plastics Prohibitions Regulations - Technical guidelines developed to provide information about the requirements of the regulations

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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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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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)