Bulletins, Consultations & Updates

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 Regulatory Matters e-comm or Bite-Sized News e-newsletter.

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 Canada.

If you wish to share feedback with DIAC regarding any open consultations with Health Canada, 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 Canada's consolidated direct response to consultations. 

This page is for  HEALTH CANADA Regulatory Updates and Info only - Please Click Here to visit the General Regulatory Bulletins page

Health Canada

2023

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November 15, 2023 - Health Canada Revised Notice: Implementing the regulatory enrolment process (REP) for medical devices regulatory activities

The Health Products and Food Branch (HPFB) is implementing the regulatory enrolment process (REP) and use of the Common Electronic Submissions Gateway (CESG) for medical device regulatory activities. The REP will be used to collect information from manufacturers on the company, dossiers, devices, regulatory activities and transactions. It consists of a set of web-based templates that generate REP Extensible Markup Language (XML) files upon completion.

Our goal is to implement a common submission intake approach for all product lines. This includes the following:

• a single process for all regulatory transactions to eliminate the use of media (such as CDs and DVDs) to transmit transactions and expand the scope of the CESG to allow regulatory transactions in non-eCTD format
• regulatory activities filed through the CESG with the REP are more efficient and secure compared to using courier and email
• web-based REP templates for easier and faster data entry including drop-down lists, predictive text and help text
• easier method for uploading data into Health Canada systems, as REP files sent by manufacturers are in XML format to enhance accuracy, consistency and reliability of the information captured

The REP is available for the following activities:

• Class II, III and IV licence applications
• Class II, III and IV licence amendments
• Class II, III and IV minor change amendments (faxbacks), including manufacturer name and/or address change
• Class II, III and IV private label applications
• Class II, III and IV private label amendments

All regulatory submissions must be prepared using the International Medical Device Regulators Forum (IMDRF) table of contents format.

Before using this process for the first time, manufacturers should become familiar with REP templates, help instructions, CESG requirements, and the REP medical device guidance document. These items will be posted on our REP information web page by December 2023.

Health Canada intends to make REP mandatory within 18 months from the implementation date.

Learn More

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October 24, 2023 - Health Canada has published Guiding Principles developed with the US FDA and UK MHRA on pre-determined change control plans (PCCPs) for machine learning-enabled medical devices (MLMD)

This document builds on a 2021 joint publication with Medtech Canada on general principles for Good Machine Learning Practice (GMLP), and provides foundational considerations for robust PCCPs.

In 2021, the U.S. Food and Drug Administration (FDA), Health Canada and the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) jointly identified 10 guiding principles that can inform the development of good machine learning practice (GMLP). In this document, FDA, Health Canada and MHRA jointly identified 5 guiding principles for predetermined change control plans. 

Advancements in digital health technologies include artificial intelligence/machine learning-enabled medical devices (MLMDs). Regulatory expectations that are aligned with best practices for development and change management, such as those described in the GMLP guiding principles, can help to support the quality of such devices. Ultimately, this can lead to patient benefits such as earlier access to innovative technologies or more accurate diagnoses.

The change management process helps to ensure the ongoing safety and effectiveness of devices in the face of change throughout the device's total product lifecycle (TPLC). However, certain changes to MLMDs, such as changes to a model or algorithm, may be substantive or significant. For this reason, they can require regulatory oversight, such as additional premarket review. Such regulatory expectations may not always coincide with the rapid pace of MLMD development.

Related links:

• Good machine learning practice for medical device development: Guiding principles

Learn More

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September 11, 2023 - Health Canada has launched a 60-day public consultation on Draft Guidance for Determining Medical Device Application Type

Health Canada is seeking feedback from medical device manufacturers and other medical device stakeholders on the draft Guidance for determining medical device application type.

This guidance:

• explains the different application types
• will help manufacturers determine whether certain medical devices, including components and parts, should be combined and submitted as 1 device licence or authorization application

In particular, Health Canada would like feedback on the:

• overall clarity and content
• criteria for different application types
• examples provided

The input gathered through this process will be used to finalize the guidance document. The final document will replace the Guidance for the interpretation of sections 28 to 31: Licence application type.

Send an email to mddpolicy-politiquesdim@hc-sc.gc.ca with your ideas or comments to make yourself heard.

Learn More

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September 6, 2023 - Health Canada has published an updated MDEL Guidance Document (GUI-0016)

This guidance document is intended for any person in the medical device industry. It replaces GUI-0016 version 8 (April 1, 2020).

Guidance on Medical Device Establishment Licensing (GUI-0016) provides guidance on the regulatory requirements for medical device establishment licences (MDELs), including:

when and how to apply for an MDEL and

how to maintain an MDEL once issued

This guidance document explains:

• medical devices establishment licensing under sections 44 to 51.1 of the Medical Devices Regulations (MDR) to the Food and Drugs Act (act)
• responsibilities of any person who imports or distributes medical devices in Canada
• Health Canada's responsibilities.

This guidance document covers licensing requirements for MDELs, including who requires an MDEL. It describes how to:

• apply for an MDEL
• submit an annual licence review before April 1 of each year
• make change(s) to your existing licence (for example, an amendment or section 48 notification)
• cancel your MDEL
• reinstate your licence after a suspension

Learn More

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August 30, 2023 - Health Canada Consultation on MLMD Draft Guidance Now Open

Share your views: Draft Pre-market guidance for machine learning-enabled medical devices

With the increase in artificial intelligence and machine learning in medical devices, Health Canada has developed the Draft Pre-market guidance for machine learning-enabled medical devices.

This guidance:

• helps manufacturers who submit an application for a machine learning-enabled medical device (MLMD)
• outlines our expectations for demonstrating the safety and effectiveness of an MLMD throughout its lifecycle
• introduces a mechanism to pre-authorize planned changes to an MLMD to address risks through a pre-determined change control plan (PCCP)

Health Canada is seeking to engage with medical device stakeholders, including manufacturers of Class II to IV medical devices, regulatory representatives, and machine learning experts.

Key questions for discussion

Health Canada invites you to provide feedback on the overall clarity and content of the draft guidance.

We also would like you to answer the following questions:

• Do we need to add or remove information on the device's intended use or description?
• Do you agree that risk analyses are important in determining if all applicable risks are mitigated appropriately? Do you support their evaluation by Health Canada? Should other risks be listed?
• Data selection, training and testing must be done correctly to ensure appropriate performance in the real world. Are the data selection and training elements appropriate? Should other considerations be made?
• Are the minimum clinical evidence requirements reasonable for this new technology? Are there challenges in demonstrating the impacts on different sexes, genders and under-represented populations?
• Transparency of any machine learning system is important to Health Canada. Users should know what the system is meant to do, the composition of its training data, and its performance and limitations. What information should we add or remove?
• What information should we add or remove from the PCCP sections?

Health Canada will use the comments we receive to finalize the guidance document. Your feedback will help us clarify the factors that applicants should consider to demonstrate that the device is safe, effective and of high quality throughout its lifecycle.

Send an email to mddpolicy-politiquesdim@hc-sc.gc.ca with your ideas or comments to make yourself heard. Consultation period closes on October 29th, 2023. 

DIAC members may also send comments by email to info@diac.ca for inclusion in a consolidated industry response in collaboration with Medtech Canada. 

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August 29, 2023 - Senior Management Announcement - Health Products and Food Branch, Health Canada

DIAC received the following communication from Health Canada on August 29, 2023:

A Note from Pam & Celia

It is with mixed feelings that we are informing you that David Boudreau, Director General, Medical Devices Directorate, has accepted a new position with the Courts Administration Service (CAS), effective September 5, 2023. David will lead the implementation of legislative amendments stemming from Bill C-13, an Act for the Substantive Equality of Canada's Official Languages. Bill C-13 imposes new legislative obligations requiring that all Court decisions of precedential value are issued simultaneously in both official languages. 

David joined the Health Products and Food Branch in January 2018 as the Executive Director of the Medical Devices Bureau. In January 2020, he became Director General with the creation of the new Medical Devices Directorate. With the support from his team, he has shown leadership in establishing solid relationships with key stakeholders, setting up the new Directorate, and navigating the pandemic while ensuring continuous access to COVID medical devices. We would also like to thank David for his leadership in fostering a bilingual work environment. On a personal note, we will miss David’s positive and collaborative approach, and I thank him for the warm welcome when I initially joined the Branch. David, you will be missed.

We are also pleased to announce that Bruce Randall will be acting DG, Medical Devices as of September 11.

Please join us in congratulating David and wishing him all the best in his new role.

Pam Aung Thin
Assistant Deputy Minister
Health Products and Food Branch, Health Canada

Celia Lourenco
Acting Associate Assistant Deputy Minister
Health Products and Food Branch, Health Canada

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August 28, 2023 - URGENT SURVEY for DIAC Members - Deadline Extended to August 31, 2023

PMRA Impact Assessment - Medical Devices with Preservatives/Antimicrobials

DIAC has been engaging actively with PMRA, Health Canada and Medtech Canada on new PMRA requirements taking effect this year.

On June 5th, a new PMRA requirement went into effect requiring all Class 1 Medical Devices that contain preservatives to have their preservative listed on the PMRA Preservative list.

Together with Medtech Canada, DIAC met with PMRA and Health Canada on two occasions, most recently June 30th, 2023. Following the latest meeting, Heath Canada is seeking further industry feedback on all classes of Medical Devices containing Preservatives and/or Antimicrobials (whether they are treated articles or not).

as we have escalated concerns to PMRA and Health Canada relating to the 6-month compliance timeline, the cost-prohibitive nature of the registration process, a lack of industry consultation, and foreseeable Medical Device shortages. We are URGENTLY seeking member feedback

This survey is being conducted jointly by DIAC, Medtech Canada, and Food Health & Consumer Products of Canada (FHCP). Individual responses are confidential (we are unable to see who responded unless you provide your contact information).

Click here to complete the survey

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August 2, 2023 - Health Canada Licencing Challenges

Medtech Canada has aligned with Health Canada to initiate ongoing meetings regarding licencing submission challenges that its members have been facing. The goal of these meetings is to collaborate and identify issues, resolve concerns and align on future efficiencies.

DIAC members are encouraged to bring forward issues they have faced when applying for medical device licences.

The following Survey is always open for you to provide your feedback: https://forms.office.com/r/pBDmJsbSUm or you may share your feedback via email with info@diac.ca

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August 1, 2023 - URGENT SURVEY for DIAC Members - Deadline Extended to August 11, 2023

PMRA Impact Assessment - Medical Devices with Preservatives/Antimicrobials

DIAC has been engaging actively with PMRA, Health Canada and Medtech Canada on new PMRA requirements taking effect this year.

On June 5th, a new PMRA requirement went into effect requiring all Class 1 Medical Devices that contain preservatives to have their preservative listed on the PMRA Preservative list.

Together with Medtech Canada, DIAC met with PMRA and Health Canada on two occasions, most recently June 30th, 2023. Following the latest meeting, Heath Canada is seeking further industry feedback on all classes of Medical Devices containing Preservatives and/or Antimicrobials (whether they are treated articles or not).

We are URGENTLY seeking member feedback as we have escalated concerns to PMRA and Health Canada relating to the 6-month compliance timeline, the cost-prohibitive nature of the registration process, a lack of industry consultation, and foreseeable Medical Device shortages.

Please note - This survey is being conducted jointly by DIAC, Medtech Canada, and Food Health & Consumer Products of Canada (FHCP). Individual responses are confidential (we are unable to see who responded unless you provide your contact information).

Click here to complete the survey

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July 31, 2023 - Health Canada Investigational Testing Authorization (ITA); Notification process to be introduced

Medtech Canada has shared the news that a Health Canada Notice in relation to a new notification process for certain types of medical device clinical trials can be expected in the coming months.

As you may be aware, an investigational testing authorization (ITA) is required for unlicensed Class II, III, and IV medical devices that will be imported and/or sold in Canada for the use in clinical trials. Health Canada has previously outlined in guidance that some clinical trials conducted in Canada do not require an ITA.

In order to assess the safety of clinical trial participants and to gain a broader understanding of medical device clinical trials in Canada, Health Canada plans to introduce a notification process for two types of clinical trials:

• In-house clinical trials
  Investigator-led clinical trials that use a licensed medical device, but not according to the Canadian-licensed intended use

Prior to enrolling patients in one of these types of trials, information regarding the study (such as investigational site information, a brief description of the device, a brief protocol summary, etc.) would be required to be provided to Health Canada. A Notification Form is being developed to facilitate information collection. An authorization will not be issued under this notification process, and the investigator would be able to proceed to enroll clinical trial participants once the notification was submitted to Health Canada (and following Research Ethics Board approval). Health Canada plans to review the information provided for each trial, and we could follow up for additional information if necessary.

Once the Notice itself is finalized, it will be shared with Medtech Canada and with DIAC members. Health Canada is open to organizing a call/webinar to discuss further if members have questions. If a webinar is scheduled, information on how to register/attend will be shared on this page.

Health Canada is currently NOT planning to make information (submitted on) the Notification Form public.

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July 24, 2023 - Health Canada has provided clarification on the importer responsibilities around foreign reporting under Part 1.1 of the Medical Devices Regulations (SOR/98-282)

In response to an inquiry from Medtech Canada, Health Canada provided clarity around the timelines expected to update the regulations. The response from Health Canada is provided verbatim below:

Subsection 68.3(3) of the regulations indicates a legislative intent that an importer would be required to prepare a report under section 61.2 in regards to a COVID-19 medical device even if the manufacturer of the device holds a Part 1.1 authorization. It is recognized that the regulations are unclear in this regard. Therefore, given the current state of the regulations and since there is a legislative intent, importers are expected to, and should, submit foreign risk notifications about authorised devices.

The regulations will be amended in the future to make it explicit that applies to importers via the next regulatory amendment.

The Medical Devices Regulations (SOR/98-282) can be found here on the Government of Canada website.

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July 17, 2023 - URGENT SURVEY for DIAC Members

PMRA Impact Assessment - Medical Devices with Preservatives/Antimicrobials

DIAC has been engaging actively with PMRA, Health Canada and Medtech Canada on new PMRA requirements taking effect this year.

On June 5th, a new PMRA requirement went into effect requiring all Class 1 Medical Devices that contain preservatives to have their preservative listed on the PMRA Preservative list.

Together with Medtech Canada, DIAC met with PMRA and Health Canada on two occasions, most recently June 30th, 2023. Following the latest meeting, Heath Canada is seeking further industry feedback on all classes of Medical Devices containing Preservatives and/or Antimicrobials (whether they are treated articles or not).

We are URGENTLY seeking member feedback as we have escalated concerns to PMRA and Health Canada relating to the 6-month compliance timeline, the cost-prohibitive nature of the registration process, a lack of industry consultation, and foreseeable Medical Device shortages.

Please note - This survey is being conducted jointly by DIAC, Medtech Canada, and Food Health & Consumer Products of Canada (FHCP). Individual responses are confidential (we are unable to see who responded unless you provide your contact information).

Click here to complete the survey

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July 4, 2023 - Health Canada has published proposed amendments to the Radiation Emitting Devices Regulations pertaining to laser products in the Canada Gazette Part I 

Health Canada has published proposed amendments to the pertaining to laser products in the to gather input on the proposed amendments and the potential impact they may have on regulated parties and interested Canadians. Radiation Emitting Devices Regulations Canada Gazette Part IInterested persons may make representations concerning the proposed regulations during the 75-day comment period (July 1 – September 14, 2023).

You are strongly encouraged to use the online regulatory commenting feature (see annex A for description and instructions) that is available on the website but if you use email, mail or any other means, the representations should cite the , Part I, and the date of publication of this notice, and be sent to Tara Bower, Director, Office of Science Policy, Liaison and Coordination, Department of Health, Postal Locator 4908D, 269 Laurier Avenue West, Room 8016, Ottawa, Ontario K1A 0K9, (email:  hc.erhsdgeneral-dssergenerale.sc@hc-sc.gc.ca).

All stakeholder comments that conform to the terms of use will be posted online after the comment period for the proposed regulation ends.

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June 29, 2023 - Cancellation of MDELs for non-compliance with annual licence review requirements Part I 

An annual licence review (ALR) ensures that medical device establishment licence (MDEL) holders are complying with regulatory requirements associated with the Medical Devices Regulations (regulations). An ALR also ensures that their licence information is up-to-date.

As a courtesy, Health Canada sends an ALR application package to all active MDEL holders at the end of each calendar year. We also sent out 2 reminder notices to the licence contact person on file in February and March 2023. To continue doing business, active MDEL holders must submit an ALR application before April 1 of each year as per the regulations. Licence holders with a suspended MDEL do not need to apply.

Health Canada will cancel the MDEL for those licence holders who do not submit their ALR application to us within the required timeline. Active MDEL holders must also notify us within 15 calendar days if they change their contact information. This includes changing the name or address of their establishment or the information of the establishment representative associated with their MDEL.

Since the ALR deadline of April 1, 2023, 264 MDEL holders have not submitted an ALR application for the 2023/2024 fiscal year. We have cancelled their MDELs and removed them from the list of active medical device establishment licences. MDEL holders whose establishment licence is cancelled cannot conduct licensable activities. This includes Class I manufacturers that distribute their own devices.

Cancellation means that MDEL holders:

• may not distribute or import all classes of medical devices
• must stop their activities as soon as they receive their cancellation notice

To resume licensable activities, companies whose MDEL has been cancelled must re-apply for a new establishment licence. They must also pay the applicable fee. For more information on how to re-apply for an MDEL, please refer to the following guidance documents:

• Guidance on medical device establishment licensing (GUI-0016)
• Fees for the review of medical device establishment licence applications

In line with our compliance and enforcement policy, Health Canada carries out compliance monitoring activities. Cancelled MDEL holders may be subject to compliance and enforcement actions if we find they are conducting non-compliant activities.

Learn more:

• Compliance and enforcement policy for health products (POL-0001)

For questions about medical device establishment licencing and the application process, contact the Medical Devices Establishment Licence Unit by email: mdel.questions.leim@hc-sc.gc.ca. For questions about invoicing and fees for an MDEL, contact the Cost Recovery Invoicing Unit by email: criu-ufrc@hc-sc.gc.ca.

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June 15, 2023 - Notice: Implementing the regulatory enrolment process (REP) for medical devices regulatory activities

The Health Products and Food Branch (HPFB) is implementing the regulatory enrolment process (REP) and use of the Common Electronic Submissions Gateway (CESG) for medical device regulatory activities. Our decision is based on the results of a pilot project, which began in November 2019 and will end in December 2023. About 40 companies participated in the pilot.

The pilot was positive. All medical device companies are now invited to begin to use this process beginning in January 2024.

At the moment, the REP is voluntary.

The REP will be used to collect information from manufacturers on the company, dossiers, devices, regulatory activities and transactions. It consists of a set of web-based templates that generate REP Extensible Markup Language (XML) files upon completion.

Our goal is to implement a common submission intake approach for all product lines. This includes the following:

• a single process for all regulatory transactions
  • will eliminate the use of media (such as CDs and DVDs) to transmit transactions to us
  • will expand the scope of the CESG to allow regulatory transactions in non-eCTD format
• regulatory activities filed through the CESG with the REP
  • is more efficient and secure compared to using courier and email
• web-based REP templates for easier and faster data entry
  • features include drop-down lists, predictive text and help text
• easier method for uploading data into Health Canada systems, as REP files sent by manufacturers are in XML format
  • will enhance accuracy, consistency and reliability of the information captured

The REP is available for the following activities:

• Class II, III and IV licence applications
• Class II, III and IV licence amendments
• Class II, III and IV minor change amendments (faxbacks), including manufacturer name and/or address change
• Class II, III and IV private label applications
• Class II, III and IV private label amendments

All regulatory submissions must be prepared using the International Medical Device Regulators Forum (IMDRF) table of contents format.

The following activities are not part of the REP:

• investigational testing applications (ITA)
• medical device establishment licence (MDEL) applications
  • for example, Class I medical devices
• Special Access Program (SAP) applications
• medical devices regulated under Part 1.1 of the Medical Devices Regulations (for use in relation to COVID-19)

Before using this process for the first time, manufacturers should become familiar with the following:

• REP templates
• help instructions
• CESG requirements
• REP medical device guidance document

These items will be posted on our REP information web page by December 2023.

Health Canada intends to make REP mandatory within 18 months from the implementation date.

For questions about this notice or about the REP in general, email us at devicelicensing-homologationinstruments@hc-sc.gc.ca.

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June 14, 2023 - An update on amendments to the Food and Drugs Act for the assessment and management of environmental risk from drugs 

The government introduced Bill S-5 (Strengthening Environmental Protection for a Healthier Canada Act) in the Senate on February 9, 2022. The Bill modernizes the Canadian Environmental Protection Act, 1999 (CEPA) and amends the FDA to incorporate an environmental purpose. Bill S-5 was approved by both the Senate and the House of Commons and received Royal Assent on June 13, 2023.

The amendments to the FDA expand the Minister of Health’s authorities by:

• Adding a suite of legislative environmental risk management tools for therapeutic products. These provisions build upon the authorities in place under the FDA for health and safety purposes (such as mandatory recalls, fines and penalties); and
• Providing the ability to create regulations to assess and manage environmental risks from products regulated under the FDA.

The new suite of legislative environmental risk management authorities will come into force upon Royal Assent (i.e., will not require the development of regulations to support their use); however, we do not intend to use these provisions in the absence of published guidance. These authorities will provide the ability to quickly and effectively manage environmental risks posed by therapeutic products. It is anticipated that these authorities would be used sparingly and under exceptional circumstances. These authorities include:

The power for the Minister to order an authorization holder to compile information, conduct certain tests/studies/monitoring, and to provide the information or results if the Minister needs additional information about the effects on the environment of a therapeutic product that is already on the market (s.21.33);

The power to disclose confidential business information about a therapeutic product [ss.21.301(3)] to another government/jurisdiction if the purpose of the disclosure is related to the protection of the environment; and

If the Minister believes that a therapeutic product, that is already on the market, may present a serious risk to the environment:

i. The power to require additional information [ss.21.301(1)] that is in a person’s control and that is necessary to determine whether the product presents such a risk;

ii. The power to publicly disclose confidential business information about a therapeutic product [ss.21.301(2)];

iii. The power to order a label change or package modification (s.21.302) if the Minister believes that doing so is necessary to prevent a serious risk to the environment from a therapeutic product, that is already on the market; and

iv. The power to recall a therapeutic product (s.21.303), that is already on the market.

Guidance to support the use of these provisions is currently being developed on when and how Health Canada would use these FDA post-market environmental risk management provisions. This guidance document will be similar to the existing guidance document for human health risk management provisions (i.e., Amendments to the Food and Drugs Act: Guide to New Authorities; Vanessa’s Law) and will be shared for consultation before they are published.

In addition, the authority now exists under the FDA to create regulations to assess and manage environmental risks for all FDA-regulated products (i.e., food, drugs, cosmetics and devices), however only regulations for drugs are being contemplated at this time. The amendments that support the development of this framework will come into force at a later date, aligning with the publication of the associated regulations.

Should you have any questions, please send them to Health Canada’s Environmental Regulatory Initiative at: ear-ree@hc-sc.gc.ca.

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DEPARTMENT OF THE ENVIRONMENT & DEPARTMENT OF HEALTH

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

RELATED PUBLICATIONS:

1) May 20, 2023 - Draft State of Per- and Polyfluoroalkyl Substances (PFAS) Report Published

Per- and polyfluoroalkyl substances (PFAS) are a class of over 4700 human-made substances. These substances have a wide range of uses in products available to consumers, industrial applications, and other specialized applications. The widespread use of these substances and their extreme persistence in the environment, propensity for accumulation, and mobility has led to PFAS being commonly detected in the environment and humans. Despite data having largely been generated on a limited suite of well-studied PFAS, there is a growing body of evidence that exposure to other PFAS can lead to adverse effects on the environment and human health. Cumulative effects from co-exposure to multiple PFAS may also occur.

This report provides a qualitative assessment of the fate, sources, occurrence, and potential impacts of PFAS on the environment and human health to inform decision-making on PFAS in Canada.

View and download the report

2) May 20, 2023 - Risk Management Scope for Per- and Polyfluoroalkyl Substances (PFAS) Published

This document outlines the proposed risk management options under consideration for the class of per- and polyfluoroalkyl substances (PFAS), which have been proposed to be harmful to the environment and human health.

View and download the risk management scope

3) May 20, 2023 - Supporting document published: Ecological state of the science report on Short-chain (C4–C7) Perfluorocarboxylic Acids (SC-PFCAs) Short-chain (C4–C7) Perfluorosulfonic Acids (SC-PFSAs) Long-chain (C9–C20) Perfluorosulfonic Acids (LC-PFSAs)

This document contains additional information that is summarized or referenced in the Draft State of Per-and Polyfluoroalkyl Substances (PFAS) Report. Relevant data were identified up to March 2022.

In the Draft State of PFAS Report, this document is referenced as:

[ECCC] Environment and Climate Change Canada. 2023. Supporting Document: Ecological State of the Science Report on Short-chain PFCAs, Short-chain PFSAs, and Long-chain PFSAs. Gatineau (QC): Government of Canada.

View and download this supporting document

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April 15, 2023 - New Consultation - Regulations Amending Recalls, Establishment Licences and Finished Product Testing 

Health Canada published the proposed amendment “Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing)”, on April 15, 2023.

This consultation is open from April 15, 2023, and will close on June 29, 2023.

Health Canada is proposing amendments to the FDR and the MDR that would deliver on departmental commitments to establish clear obligations for industry when conducting recalls of therapeutic products and strengthen Health Canada’s oversight of these recalls. To improve international alignment for firm-initiated recalls, proposed amendments to the MDR would require recalls to be reported based on the level of risk, and require all recall records to be kept. The proposed amendments to the FDR and MDR would also introduce reporting obligations for a person who is ordered by the Minister to recall a therapeutic product.

These proposed amendments to the Medical Devices Regulations might impact the following topics:

• Recalls (deadlines, reposts, and records)
• MDEL (updates, and Terms and Conditions)

Health Canada is seeking feedback on the proposed Regulations related to the MDR. Please visit the following link for more information and to provide feedback.

https://canadagazette.gc.ca/rp-pr/p1/2023/2023-04-15/html/reg1-eng.html

You may also send your comments/input by email to info@diac.ca 

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April 6, 2023 - REMINDER - 2023 MDEL ALRs

DIAC Members who are subject to Medical Device Establishment Licensing requirements are reminded that 2023 ALRs were due on April 1st. Health Canada will begin suspending MDELs in the near future.

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March 23, 2023 - Consultation – Proposed changes to Part 1.1 of the MDR on future public health emergencies

The consultation on proposed changes to the Medical Devices Regulations (MDR) to address future public health emergencies has opened on March 23, 2023. You are invited to review the notice and provide your comments before April 13, 2023.

The purpose of this notice is to advise stakeholders that Health Canada is proposing regulatory amendments to expand the current provisions under Part 1.1 of the MDR, currently limited to COVID-19 medical devices, to apply to any future public health emergency. The proposed amendments will also result in administrative changes to the Fees in Respect of Drugs and Medical Devices Order.

Health Canada is proposing to expand the scope of Part 1.1 to:

• apply to other medical conditions that present, or are the result of, a significant risk to public health in Canada, and immediate action is required to deal with the risk
• include medical devices for which there is an urgent public health need to diagnose, treat, mitigate or prevent these medical conditions

Health Canada is seeking your feedback on the proposed measures and the implications on fees. You may submit your comments by emailing the Medical Devices Directorate at mddpolicy-politiquesdim.sc@hc-sc.gc.ca or send your input to info@diac.ca 

**DIAC Members are welcome to attend a Webinar on April 12th regarding this consultation. Email info@diac.ca to request the webinar particulars.**

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March 6, 2023 - Medical Devices - Treated Articles (in relation to Proposed Amendments to the Pest Control Products Regulations)

The following links contain additional relevant information that was discussed during a meeting attended by representatives from DIAC, Health Canada and Medtech Canada on March 6, 2023:

• Regulatory Proposal PRO2018-03, Pre-Consultation – Proposed Amendments to the Pest Control Products Regulations (Product Exemptions) - Summary  

https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/public/consultations/regulatory-proposals/2018/product-exemptions/document.html 

• Information Note, Treated Articles

https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/fact-sheets-other-resources/treated-articles.html  

• Questions and Answers – Treated Articles

https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/fact-sheets-other-resources/treated-articles/questions-and-answers.html  

• Pesticide Product Information Database (contains a listing of active ingredients and end-use products that are registered in Canada. Further explained in the Q&A link above under Q10)

https://pest-control.canada.ca/pesticide-registry/en/index.html

• Compliance and enforcement policy for pesticides

https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/policies-guidelines/compliance-enforcement-policy-pesticides.html

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February 28, 2023 - Medtech Canada Circulated the Q2 Performance Report from the Medical Devices Directorate, Health Canada

Click below to review the reports in English or French:

MDD Quarterly Report-Q2-2022-23-EN.pdf

DIM Rapport trimestriel-T2-2022-23-FR.pdf

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February 23, 2023 - Consultation: Registration of Clinical Trials and Public Disclosure of Results: Draft Guidance and Public Search Portal

Health Canada has developed a draft guidance document and is proposing a clinical trials search portal. This portal would help make more Canadian authorized trial information available to the public and improve accessibility of this information.

Health Canada is seeking your feedback on:

• Draft guidance describing policy expectations for sponsors of authorized clinical trials to register and report the results of their trials with international registries
• Proposed mock-ups of a new clinical trials search portal

Who is the focus of this consultation? 

• health professionals
• patients and their caregivers and patient advocate organisations
• researchers investigating drugs, medical devices and natural health products (NHPs) in humans

Goals of the consultation:

Health Canada is committed to improving the transparency of Canadian clinical trial information. This consultation advances priority work under the Department's Forward Regulatory Plan for 2022-2024 to modernize the clinical trials regulatory framework.

For more information, Click Here. 

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February 23, 2023 - Presentation Files & Webinar Recordings from Medtech Canada’s webinar event: Overview of the MDSAP Certification Process 

The webinar, presented by Frédéric Hamelin, Manager, Quality Systems Section, Medical Devices Directorate, Health Canada took place in French on Feb 9 and in English on Feb 14. Below are links to the webinar recordings in both English & French. Presentation files are also available to view and download below:

English:

English webinar recording – Click HERE
English webinar slides

French:

French webinar recording – Click HERE
French webinar slides

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February 9, 2023 - Medtech Clarifications from Health Canada regarding Disinfectants as Medical Devices

After receiving a few questions from members on the topic of Disinfectants as medical devices, Medtech reached out to Health Canada with a few clarifying questions.

Please note below response from Health Canada on the matter of Disinfectants as Medical Devices. (Health Canada responses in blue italic font). 

1. In the above link (https://www.inspec-bv.com/health-canada-reclassifies-high-level-disinfectants-and-sterilants-as-medical-devices) it states that there is a plan to also amend these to be classified as Class III.  Is this still in play and if so is there a timelines?

At this time, MDD is not pursuing the reclassification of HLD to Class III devices via a regulatory amendment. This project has been put on hold due to other regulatory priorities and there is currently no target date for this item.  However, we continue to require manufacturers to provide information to demonstrate that the HLD meets sections 10 – 20 of the MDR upon submission.  This approach was communicated in the Notice of March 2018.  

1. The guidance for the data to be submitted for these class II devices seems to be residing in the “drug” section of the Health Canada website – is there a plan to move this to the “Medical Devices” section? 

The link to this document is on both the drugs and medical devices Guidance documents pages. 

1. What are the timelines that an applicant can expect when submitting these class II devices?  Im thinking it would not be the usual timelines expected for class II?

These devices are subject to Class II timelines and as such, first decisions have a service standard of 15 days, consistent with all Class II submissions.  A first decision can include the issuance of a request for additional information. 

There are no service standards associated with the further review of the evidence that may be required after the first decision has been issued. MDD endeavours to complete these files within timelines similar to Class III devices but acknowledges that these files tend to be extremely challenging to bring to completion.

1. Have the timelines been amended due to Covid to give companies some more time to change to MDSAP or has this already been implemented?

Manufacturers were granted an 18 month transition to obtain a QMS certificate and a medical device licence.  This transition period ended on September 16, 2019 as per the March 18, 2018 notice.

Health Canada had a transition period in 2017-2018 to move from CMDCAS to MDSAP and accepted only MDSAP certificates as of January 1, 2019. We did not offer an additional transition period for manufacturers due to COVID.

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February 1, 2023 - In Collaboration with Health Canada & Featuring Speaker from Medical Devices Directorate:

Medtech is Presenting a Live Webinar Event: 

Frédéric Hamelin
Manager, Quality Systems Section
Medical Devices Directorate, Health Canada

Tuesday, February 7, 2023 | 12:00pm - 1:30pm ET  (English)

With the anticipated implementation of regulatory changes regarding the authorisation of COVID-19 medical devices, authorisation holders may need to comply with additional requirements, including certification under MDSAP.

In this session, Frédéric Hamelin, Manager of the Quality Systems Section of the Medical Devices Directorate at Health Canada, will provide an overview of the MDSAP certification process to help authorisation holders understand this transition and the MDSAP process.

Topics will include:

-What would IO holders be required to do?
-What is MDSAP?
-What is the process for obtaining MDSAP certification?

A question and answer session will follow.

The webinar will be held in English on Tuesday, February 7 and in French on Thursday, February 9, 12:00 to 1:30 pm Eastern on both days.

Registration links:

Feb 7 – English webinar: https://medtechcanada.org/our-work/events/index.html/event-info/details/id/11

Feb 9 – French webinar: https://medtechcanada.org/our-work/events/index.html/event-info/details/id/12

Participate in the live webinar event or register to receive the webinar recording.

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January 18, 2023 - Guidance to apply for a Manufacturer's Certificate to Export licenced medical devices from Canada

Health Canada has today issued a new Guidance Document: Guidance to apply for a Manufacturer's Certificate to Export licenced medical devices from Canada (GUI-0097) which replaces Guidance to apply for a manufacturer's certificate to export licensed medical devices from Canada (2019).

This document is a guide for companies in Canada who want to obtain a manufacturer's certificate to export (MCE) licensed medical devices from Canada. This certificate is also known as a certificate of free sale. Issuing MCEs is not a regulatory requirement. It's a voluntary service provided to manufacturers by Health Canada's Regulatory Operations and Enforcement Branch (ROEB). There are currently no application fees associated with this service.

This guide is for manufacturers in Canada who plan to get an MCE in order to export medical devices from Canada to a foreign country.

Foreign governments or customers may ask companies exporting medical devices from Canada to supply a certificate. This certificate proves that their medical devices meet Canadian regulations and may be marketed in Canada. ROEB issues these certificates as a voluntary service to the Canadian medical device industry. The certificates make it easier to export licensed medical devices. An MCE includes an attestation by both the manufacturer and Health Canada. Before applying, you should confirm that your medical device licences and/or medical device establishment licences are valid.

An MCE can only be requested by someone who is located in Canada and who is:

• the manufacturer with an MDEL for Class I devices or
• the MDL holder for Class II, III or IV devices or
• the IO authorization holder for Class I, II, III and IV COVID-19 medical devices

For more information, Click Here. 

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January 10, 2023 - Health Canada and FDA eSTAR pilot: Notice to industry

eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission.

eSTAR is free and available for voluntary use for all medical device submissions for 510(k)s and De Novos sent to CDRH. The eSTAR is not currently for use with combination products. For more information on the use of eSTAR for premarket submissions, please visit the webpage Voluntary eSTAR Program.

The FDA and Health Canada are conducting a joint pilot. The pilot will test the use of a single eSTAR submitted to both the FDA and Health Canada. The feasibility of using eSTAR will be determined by the outcome of a pilot with 9 participants. Selected participants will use the non-In Vitro Diagnostic eSTAR, which follows the structure of the IMDRF Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC).

Health Canada is also launching its own pilot.  For information on Health Canada only pilot, please refer to the Health Canada eSTAR pilot program page. 

 Click here to learn more about the pilot, eligibility to participate and the process to request participation.

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January 10, 2023 - The Distinction Between Advertising and Other Activities for Health Products 

The Section for Transparency and Advertising Regulatory Surveillance within the Marketed Health Products Directorate at Health Canada conducted a policy webinar with stakeholders January 10, 2023. The discussion session focused on comments provided on the consultation draft guidance document The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products in 2019. 

Click Here to view the 2019 Draft document.

Click Here to review the slides from the January 10th webinar. 

Should you have important/critical suggestions or clarification questions you may send them to: 

Email: drug-device-marketing@hc-sc.gc.ca