Health Canada medical device regulations

Canada has one of the most stringent and well-respected regulation processes, not only for medical devices but for the overall health and safety of its citizens. Canada uses a risk-based approach to the regulation of medical devices, where the review before approval depends on the potential risk that the use of the device presents or could potentially present. Devices are categorized into four classes based on the risk, with Class I devices presenting the lowest potential risk (e.g. a tongue depressor) and Class IV devices presenting the greatest potential risk (e.g. a pacemaker).  Class II, III, and IV medical devices must have a Medical Device License to be sold in Canada, while companies selling Class I medical devices in Canada are required to have a Medical Device Establishment License (MDEL). 

The regulation of medical devices in Canada is driven by The Food and Drugs Act (R.S.C., 1985, c. F-27). This act includes food, drugs, cosmetics, and devices. The regulation specific to devices is the Medical Devices Regulations (SOR/98-282). The information within the regulations includes, but is not limited to, classification, manufacturer’s obligations, associated fees, labeling requirements, establishment license, incident reporting, recalls and much more. The most recent update to the regulation was Interim Order No. 3, Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.

Most countries have an established system in place for notifying the public (including manufacturers) of initiatives and actions that they plan to take to maintain and improve the safety of medical devices - and Canada is no different. As a department, Health Canada is responsible for administering Acts and Regulations, and for implementing government-wide regulatory initiatives. All the government's Acts and Regulations can be found on the Justice Canada website. Let’s look at some of their processes and review some of their initiatives and action plans through 2024.

Forward Regulatory Plan

Canada’s Forward Regulatory Plan is designed to share anticipated regulatory changes or actions. The forward regulatory plan gives consumers, businesses, and other stakeholders an opportunity to review and comment on anticipated changes. It should be noted though, that this forward regulatory plan can be modified at any point.

The Forward Regulatory Plan: 2022 - 2024 provides information about specific regulatory activities and initiatives that Health Canada aims to finalize through 2024. This plan sets up a timeframe for activities and initiatives to be completed. Pre-publication and final publication announcements are published in the Canada Gazette, the official newspaper of the Government of Canada.

There are currently several initiatives in this Forward Regulatory Plan including those that fall under the Consumer Product Safety Act, Hazardous Products Act, and Food and Drugs Act, to name a few.  The following are major medical device initiatives included in the plan, which fall under the Food and Drugs Act.

• Amendments to the Fees in Respect of Drugs and Medical Devices Order (Natural Health Products Fee Proposal) [New 2022-04-01]
• Advanced Therapeutic Products Pathway for Adaptive Machine Learning-enabled Medical Devices [Updated 2022-10-01]
  
• Regulations Amending the Food and Drug Regulation, Natural Health Products Regulations and the Medical Devices Regulations (Modernization of the Regulation of Clinical trials) [Updated 2022-10-01] [Associated with the targeted Regulatory Review Sectoral Roadmap] [Associated with the stock review plan]
  
• Regulations amending the Medical Devices Regulations (Agile Regulations for Licensing Medical Devices) [Updated 2022-10-01] [Associated with the targeted Regulatory Review Sectoral Roadmap] [Associated with the stock review plan]  
• Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) [Updated 2022-10-01]
  
• Modernizing the Medical Device Establishment Licensing (MDEL) Framework [Updated 2022-10-01]
  

Stock Review Plan

The Stock Review Plan is a public list and description of planned reviews of existing regulations that Health Canada is proposing within a two-year period. As of the date of this article, the on-going and proposed reviews for medical devices include:

On-going Reviews:

• ‍Regulations Amending the Medical Devices Regulations (Agile Regulations for Licensing Medical Devices), formerly referred to as Regulations Amending the Medical Devices Regulations (Agile Regulations)
• ‍Modernizing Medical Device Establishment Licensing Framework including the recall of medical devices, formerly referred to as Modernizing Drug and Medical Device Establishment Licensing Frameworks – amendments to the Food and Drug Regulations and Medical Devices Regulations

Proposed new reviews:

• ‍Advanced Therapeutic Products Pathway for Adaptive Machine Learning-enabled Medical Devices

Additional regulation updates

Regulatory Initiative Plan

Health Canada’s regulatory initiative agenda aims to provide more regulatory flexibility to support innovative research and health product development and to contribute to the country's biomanufacturing and life sciences strategy.

The 5 key pillars in the regulatory innovation agenda include:

1. Modernizing clinical trial regulations
2. Enabling advanced therapeutic products
3. Agile regulations for licensing drugs
4. Agile regulations for licensing medical devices
5. Information to Canadians mobile strategy

UDI

Unique Device Identification (UDI) is a medical device requirement in most countries, but every country is at a different stage of implementing UDI requirements. So where does Canada stand with UDI? As of June 2021, Canada was exploring the feasibility of a UDI system, including options for development of a UDI database by using internal, existing infrastructures. They propose to develop this system based on the work and experience of the International Medical Device Regulators Forum (IMDRF), as well as the United States FDA’s UDI system, to help structure the principles and design of a UDI system for Canada. No further announcements have been made since the writing of this article.

COVID-19

February 2023, Canada announced a few updates relating to regulations about COVID-19 including:

• Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices
• Medical devices for use in relation to COVID-19
• List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19

Keep up to date with news and announcements from Health Canada by referring to our Medical Device Regulatory Market Profiles section on our website.

‍