2022

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December 17, 2022 - Consultation on proposed agile regulations and guidance for licensing drugs and medical devices

Health Canada is proposing new targeted provisions and regulatory amendments to the Food and Drug Regulations and Medical Devices Regulations. These changes will continue to advance our modernization agenda and help to reduce regulatory irritants and roadblocks to innovation. We are seeking feedback on both the proposed regulations and on multiple guidance documents related to the proposal.

This Consultation opened on December 17, 2022, and will close to new input on March 27, 2023, at 11:59 pm Eastern Standard Time (EST).

How to participate:

To provide feedback on the proposed regulations, submit your comments through Canada Gazette, Part I.

To submit comments on the multiple guidance documents and notices related to this proposal, please use this online stakeholder feedback form:

• PDF fillable/saveable version - 163 KB |  Microsoft Word version - 126 KB

Key items for comment

Health Canada is proposing new targeted provisions and regulatory amendments to the Food and Drug Regulations and Medical Devices Regulations as part of our modernization work. The amendments will also:

• reduce regulatory issues and roadblocks to innovation

• make Canada’s science-based regulatory system more agile and internationally aligned

The proposal also takes into account recent experience with regulatory agilities successfully piloted as part of our response to the COVID-19 pandemic. Health Canada is seeking your ideas and input on the following topics:

• using terms and conditions on drug approvals and broadening their scope for Class II, III and IV medical devices

• allowing rolling reviews of certain drug submissions, including drugs that address a public health emergency

• requiring risk management plans for higher-risk human drugs

• updating the requirements for certain drugs that claim a manufacturer’s standard

• repealing requirements for labelling of the standard for specific drugs

• repealing outdated requirements and replacing them with those that reflect current practices

• clarifying the authority to consider information obtained outside of a new drug submission to support Health Canada’s examination of that submission for a new drug

• requiring manufacturers to submit disaggregated data for new and supplemental human drug submissions

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Guidance on Clinical Evidence Requirements for Medical Devices

Two new documents were posted by Health Canada on November 15 2022. The documents are described and linked below.

1. Guidance on clinical evidence requirements for medical devices
   
   This document provides guidance to manufacturers of Class II, III and IV medical devices and regulatory representatives on the clinical evidence requirements for medical devices. Guidance is provided on:
   • when clinical data/evidence is required
   • the common methods to generate clinical data
   • how to compare devices appropriately
     
     
2. Companion document: Examples of clinical evidence requirements for medical devices
   
   This document is to be read with the Guidance on clinical evidence requirements for medical devices. It is to help manufacturers and regulatory representatives understand when clinical evidence is necessary to demonstrate the safety and effectiveness of a medical device for its intended use. Detailed examples relating to a variety of medical devices have been provided to enhance understanding.
   
   The Guidance on clinical evidence requirements for medical devices outlines the general principles and criteria for clinical evidence that must be submitted for Class III and IV licence applications. The guidance also outlines the clinical evidence that may be requested for certain Class II licence applications and other obligations throughout a device's life cycle.

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November 16, 2022 - Guidance on Clinical Evidence Requirements for Medical Devices

Two new documents were posted by Health Canada on November 15 2022. The documents are described and linked below.

1. Guidance on clinical evidence requirements for medical devices
   
   This document provides guidance to manufacturers of Class II, III and IV medical devices and regulatory representatives on the clinical evidence requirements for medical devices. Guidance is provided on:
   • when clinical data/evidence is required
   • the common methods to generate clinical data
   • how to compare devices appropriately
     
     
2. Companion document: Examples of clinical evidence requirements for medical devices
   
   This document is to be read with the Guidance on clinical evidence requirements for medical devices. It is to help manufacturers and regulatory representatives understand when clinical evidence is necessary to demonstrate the safety and effectiveness of a medical device for its intended use. Detailed examples relating to a variety of medical devices have been provided to enhance understanding.
   
   The Guidance on clinical evidence requirements for medical devices outlines the general principles and criteria for clinical evidence that must be submitted for Class III and IV licence applications. The guidance also outlines the clinical evidence that may be requested for certain Class II licence applications and other obligations throughout a device's life cycle.

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November 15, 2022 - Content from Health Canada Webinar entitled Raising Awareness – Avoiding Unauthorized Health Products Online 

Subsequent to conducting its recent webinar on avoiding unauthorized health products online, Health Canada has shared the presentation slides and handout in both English and French.

Raising Awareness - Avoiding Unauthorized Health Products Online_ENG (presentation slides).pdf

Sensibilisation _ Éviter Les Produits De Santé Non Autorisés En Ligne_FR (la présentation).pdf

Raising Awareness - Avoiding Unauthorized Health Products Online (ENG) (Handout).pdf

Sensibilisation _ Éviter Les Produits De Santé Non Authorisés En Ligne(FR) (un feuillet).pdf

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October 7, 2022 - Health Canada issues invitation to all care professionals to attend a WebEx webinar entitled: Raising Awareness – Avoiding Unauthorized Health Products Online 

The Health Product Compliance Directorate (HPCD) of the Regulatory Operations and Enforcement Branch (ROEB) within Health Canada carries out proactive risk management projects (PRMP) to verify and promote compliance, as well as gather information regarding industry’s compliance against specific regulatory requirements. These projects complement Health Canada’s routine inspection programs and reactive market surveillance activities.

As a compliance promotion initiative, Health Canada is inviting all health care professionals to attend a WebEx webinar entitled: Raising Awareness – Avoiding Unauthorized Health Products Online (Information Session for Health Care Professionals). 

Use the following link https://canada.webex.com/webappng/sites/canada/webinar/webinarSeries/register/8ed3ac0089ca4702bcbd6a8039ab7d79 to register for the session of your choice by November 4, 2022. To complete the registration, your name and e-mail address will be required.

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September 1, 2022 - Mutual Recognition Agreement between Canada and the United Kingdom on drugs/Medicinal products good manufacturing practices compliance programs

On September 1, 2022, Health Canada published an update on the status of Canada's Mutual Recognition Agreement (MRA) with the United Kingdom on drugs/Medicinal products good manufacturing practices compliance programs.

Text of the interim Canada-United Kingdom Trade Continuity Agreement (CUK TCA) can be found at the Global Affairs Canada website.

The provisions of the Canada-European Union (EU) CETA Protocol on the mutual recognition of the compliance and enforcement program regarding good manufacturing practices for pharmaceutical products are incorporated by reference to the Canada-United Kingdom Trade Continuity Agreement (CUK TCA).

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August 19, 2022 - Federal Environmental Quality Guidelines
Federal Environmental Quality Guidelines (FEQGs) are recommended chemical thresholds to support federal initiatives.

On August 19, 2022, Health Canada published Summaries of the public comments received on the Federal Environmental Quality Guidelines for Siloxane-D4, Selenium, and Aluminum

Click Here to read the Summary of public comments received on the draft FEQG for siloxane-D4

Click Here to read the Summary of public comments received on the draft FEQG for selenium

Click Here to read the Summary of public comments received on the draft FEQG for aluminum

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July 29, 2022 - Medical Devices Directorate Performance Quarterly Report

Click Here to read MDD Quarterly Medical Device Submission Performance Report: Q1-2022/23

This Quarterly Performance Report reflects activities of the Medical Devices Directorate (MDD) of Health Canada over the last five consecutive Quarters.

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July 21, 2022 - Health Canada is modernizing and transforming the Medical Devices Compliance Program

MDEL Bulletin July 21, 2022, from the Medical Devices Compliance Program

Health Canada is modernizing and transforming the MDC program to keep pace with scientific, market and supply chain developments. The COVID-19 pandemic has also driven change as a result of significant challenges, including:

• a shift to remote work
• an increase in safety and effectiveness issues with the supply chain shift
• critical shortages of medical devices such as ventilators and personal protective equipment
• a rise in regulatory non-compliance, such as false attestations about regulatory procedures
• a surge in licenced establishments due to demand for COVID medical devices and personal protective equipment

The program is modernizing and transforming its operations in 4 main areas:

• compliance and enforcement
• regulations
• business processes and information technology
• enhanced engagement

To date, the program has implemented several modernization and transformation initiatives, including:

• Strengthening compliance and enforcement by diversifying inspections
• Modernizing compliance and enforcement oversight through regulatory amendments

• Streamlining and modernizing business processes and use of information technology

• Enhanced engagement including bi-weekly meetings with industry associations to discuss issues and updates.

The program continues to explore new initiatives to benefit the public and industry, including:

• further automation of the annual licence review process
• adding a single window to the landing page for contacting MDCP
• permanent adoption of the electronic Manufacturer's Certificate to Export
• emailing MDCP Bulletins to a broader audience, beyond current licence holders
• an eLearning module to educate industry on medical device establishment licensing and post-market responsibilities

Current and future initiatives will result in:

• a more modern, agile, robust and sustainable program
• enhanced access to information on regulatory requirements and program changes
• continued access to safe, effective and high quality medical devices for people living in Canada
• simpler and automated processes for conducting business transactions and communicating with the program

Click Here to read the full bulletin from Health Canada

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June 23, 2022 - Radiation Protection in Dentistry - Recommended Safety Procedures for the Use of Dental X-Ray Equipment

On June 23, 2022, the Consumer and Clinical Radiation Protection Bureau, Environmental and Radiation Health Sciences Directorate, Healthy Environments and Consumer Safety Branch at Health Canada published the updated Safety Code 30 which pertains to Radiation Protection in Dentistry.

This document supersedes the previous version of Safety Code 30, entitled "Radiation Protection in Dentistry: Recommended Safety Procedures for the Use of Dental X-ray Equipment," which was published in 1999. The updates in this version address new dental X-ray technologies, such as hand-held devices, cone beam computed tomography and the introduction of digital image receptors replacing the use of film. These technological advancements, along with new international guidance and standards applicable to dental radiography, necessitate updates to radiation protection requirements and practices.

Click Here to read and download the full document from Health Canada.

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June 9, 2022 - Updates to list of medical devices for mandatory shortage and discontinuation reporting

MDEL Bulletin June 9, 2022, from the Medical Devices Compliance Program

Health Canada has updated the List of Medical Devices – Notification of Shortages on June 9, 2022, to remove the medical device classification headers. All medical devices listed on the List of Medical Devices – Notification of Shortages require mandatory reporting by manufacturers and importers, regardless of the class of the medical device.

Click Here to read the full bulletin from Health Canada

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June 7, 2022 - Guidance to market authorization holders on issuing health product risk 

Health Canada is pleased to announce the release of its Guidance to market authorization holders on issuing health product risk communications. The purpose of this document is to assist market authorization holders (MAHs) develop and disseminate health product risk communications.

This document is considered an update to, and a replacement of, the guidance document formerly known as Guidance Document for Industry – Issuance of Health Professional Communications and Public Communications by Market Authorization Holders. It reflects changes in terminology and processes that have occurred since the former document’s last publication. We anticipate that many MAHs are already aware of these changes as they have been implemented in practice over the last several years.

Questions related to this guidance document can be directed to:
Risk Communication Section
Office of Policy, Risk Advisory, and Advertising
Marketed Health Products Directorate
Health Products and Food Branch, Health Canada
E-mail: riskcommunications-communicationdesrisques@hc-sc.gc.ca

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May 2022 - Health Canada Review Templates

Health Canada Review Templates for Class III and Class IV Medical Devices (Non-IVD and IVDs) are provided for DIAC Members' convenience.

Health Canada - Medical Devices - Class4nonIVD_Template.pdf

Health Canada - Medical Devices - Class4IVD_Template.pdf

Health Canada - Medical Devices - Class3nonIVD_Template.pdf

Health Canada - Medical Devices - Class3IVD_Template.pdf

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May 30, 2022 - Cancellation of MDELs for non-compliance with annual licence review requirements

MDEL Bulletin, May 30, 2022, from the Medical Devices Compliance Program

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.

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. This authority is set out in section 51.1(b) of the Regulations.

Since the ALR deadline of April 1, 2022, 395 MDEL holders have not submitted an ALR application for the 2021/2022 fiscal year. As this violates section 46.1 of the MDR, we have cancelled their MDELs and removed them from the active MDEL live listing.

MDEL holders whose establishment licence is cancelled cannot conduct licensable activities. To resume licensable activities, companies whose MDEL has been cancelled must re-apply for a new establishment licence, as per section 45 of the Regulations. They must also pay the applicable fees.

For questions about medical device establishment licensing and the application process, contact the Medical Device Establishment Licensing Unit by email:  mdel.questions.leim@hc-sc.gc.ca.

Click Here to read the full bulletin from Health Canada

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May 18, 2022 - Updates to list of medical devices for mandatory shortage and discontinuation reporting

MDEL Bulletin May 18, 2022, from the Medical Devices Compliance Program

Health Canada has updated the List of Medical Devices – Notification of Shortages on May 18, 2022, to add and remove medical devices that require mandatory reporting by manufacturers and importers.

Manufacturers of Class I to IV devices and importers of Class I medical devices should check the list of medical devices regularly. As stated in sections 62.23 to 62.25 of the Regulations, you must report shortages and discontinuations of specified medical devices to Health Canada. A medical device also includes its components, accessories or parts.

For more information on medical device shortage reporting, please refer to the:

• medical device shortages web page
• Guide to reporting medical device shortages and discontinuations (GUI-0137)

Click Here to read the full bulletin from Health Canada

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May 4, 2022 - Updates to list of medical devices for mandatory shortage and discontinuation reporting

MDEL Bulletin 2022-05-04, from the Medical Devices Compliance Program

Health Canada has updated the List of Medical Devices – Notification of Shortages on April 22, 2022, to include additional medical devices that require mandatory reporting by manufacturers and importers. 

Health Canada maintains and regularly updates this list, which is incorporated by reference (IBR) into the Medical Devices Regulations.

Manufacturers and importers are also encouraged to report shortages and discontinuations for medical devices not found on the List of Medical Devices – Notification of Shortages.

To report shortages (including voluntary shortage reports), complete the electronic shortages reporting form.

To report discontinuations that will lead to a shortage (including voluntary discontinuation reports), complete the electronic discontinuation reporting form.

Click Here to read the full bulletin from Health Canada

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February 24, 2022 - Summary of consultation responses on proposed regulatory requirements for laser devices

Health Canada thanks respondents for their participation in the consultation on proposed changes to the regulatory requirements for lasers, outlined in Schedule II of the Radiation Emitting Devices Regulations (REDR).

The consultation, conducted online between June 30, 2021, and August 30, 2021, solicited feedback from stakeholders on proposed changes aimed at enhancing the safety of laser devices that are imported, sold, leased, or advertised in Canada. 

CLICK HERE to review the summary of feedback received. 

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February 23, 2022 - Report on the Clinical Trials Regulatory Modernization Initiative Published

Health Canada has published the What We Heard Report on the consultations that were conducted on Clinical Trials Regulatory Modernization in the spring and summer of 2021.

Health Canada would like to thank all stakeholders who provided comments during the consultation period. Health Canada will continue to engage stakeholders and subject matter experts as this initiative progresses.

Please continue to consult the Forward Regulatory Plan 2021-2023: Modernization of the Regulation of Clinical Trials for updates and future opportunities to provide your feedback on this important initiative.

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February 21, 2022 - Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19

This order supports Canada’s ongoing focus on dealing with the continued risk that COVID-19 poses to the health and safety of Canadians. It contributes to securing Canada’s medical device supply chain.

Click here to view the Interim Order

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February 17, 2022 - Consultation - List of Recognized Standards 

The Health Canada Medical Devices Directorate is planning to change the way they publish the List of Recognized Standards (LORS) and is seeking feedback from MedTech for an early perspective on the industry response to the proposed plan. The intent of the change is to improve the timeliness and predictability of updates to the LORS, including the predictability of transitions to new editions of currently recognized standards. (For reference, the current list can be accessed here.)

The details of the change are outlined in the attached written communication. MDD would appreciate Medtech’s general feedback on the plan, potential pros and cons of the plan, and on the proposed wording of the notice that would explain the new method of displaying the LORS.

DiAC members should submit any comments regarding this proposal to rhondalawson@diac.ca no later than March 11th for consolidation and submission to MedTech. 

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February 16, 2022 - Regulations to allow exceptional importation of medical devices to address shortages as of March 2, 2022

Medical Devices Compliance Program Bulletin

Amendments to the Medical Devices Regulations (MDR), published in Canada Gazette, Part II in September 2021, come into force on March 2, 2022. The amendments will allow for the exceptional importation and sale of medical devices to help address shortages in Canada.

Health Canada has published draft guidance for exceptional importation and sale of medical devices. You may send your comments on the draft guidance by February 21, 2022, directly to: mdcu-ucim@hc-sc.gc.ca. 

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January 31, 2022 - Annual Cost Recovery Stakeholder Meeting 

The Fees in Respect of Drugs and Medical Devices Order was published in May 2019 and came into force on April 1, 2020. At that time, Health Canada made a commitment to engage with stakeholders annually to discuss key elements of cost recovery including performance, costs and program efficiencies.

Originally, the Annual Cost Recovery Stakeholder meeting was scheduled to take place in spring 2020; however, due to the COVID-19 pandemic, the meeting was postponed. The meeting will now take place in February, and will consist of four virtual sessions -articulated around specific health products and services.

The sessions will take place over Zoom, with simultaneous translation available.

If you would like to participate, please register for your preferred session(s) up to 24 hrs before each event by clicking on the title and a formal invitation will be sent to you. The dates for each session are indicated below:

Humans Drugs – Innovators and Biologics session

Tuesday, February 15 1:00pm - 3:30pm EST

Medical Devices session

Tuesday, February 22 1:00pm - 3:30pm EST

Humans Drugs – Generics, OTCs and Biosimilars session

Thursday, February 24 1:00pm - 3:30pm EST

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January 31, 2022 - Stakeholder Survey on Health Canada Programs

Health Canada invites you to complete a short survey. At this time, they are looking to engage stakeholders for feedback and satisfaction survey on HC programs.

The survey results will help improve the Program’s performance and ultimately better meet the needs of partners and stakeholders. It should take five to seven minutes to complete.

Please consider filling out the survey, before February 15^th, 2022, at: https://ca1se.voxco.com/SE/?st=15h1WlL2SWZSuN9HWgsVzwa5qJkA2MtNDbiSetBucoc%3D&lang=en

Questions or comments? Contact HPFB.Plann-Perform.Network@hc-sc.gc.ca

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January 20, 2022 - Consultation on the renewal of the Official Languages Health Program 2023-2028

From January 20 - February 25, 2022, Health Canada is seeking input about personal experiences of members of official language minority communities (Francophones outside Quebec and Anglophones in Quebec) in accessing health services in the official languages of their choice and to know respondents' interests for the 2023-2028 phase of the Official Languages Health Program (OLHP).

You can provide your input by completing the online questionnaire

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January 7, 2022 - MDCP Bulletin- Modernizing the Medical Device Licensing Framework (Phase I)

On December 11, 2021, Health Canada published a Notice of Intent describing a regulatory proposal that would modernize elements of the Food and Drug Regulations (FDR) and Medical Device Regulations (MDR) under the Food and Drugs Act. These amendments would strengthen Health Canada’s ability to provide efficient, effective, and agile oversight of medical devices and drugs and would contribute to addressing initiatives outlined in the Health and Biosciences Review Roadmap related to compliance and enforcement.

You are invited you to comment on the online notice by Wednesday February 11, 2022. To facilitate your ability to comment, click below to download a detailed summary of the proposed amendments to the MDR. Also provided below for download is a cost-benefit analysis survey regarding the proposal which will help Health Canada to understand the impact of the proposed amendments to the MDR. Please complete the survey and return it to prsd-questionsdspr@hc-sc.gc.ca by February 11, 2022.

Stakeholder CBA Survey - MDELMod EN.docx

Stakeholder CBA Survey - MDEL Mod FR.docx