Pharmaceutical Regulations for Medical Devices in Canada

Canada has established a rigorous pharmaceutical regulatory system to ensure the safety and efficacy of medical devices. Health Canada oversees medical device regulation and operates under the Medical Devices Regulations. As of 2025, Canada has a population of approximately 40 million people, making it the second-largest medical device market in North America after the United States.

Medical Device Classification System

Canada classifies medical devices into four classes based on risk. These range from Class I to Class IV, with higher numbers indicating higher levels of risk.

Class I: Lowest risk devices (e.g., non-sterile bandages, stethoscopes)
Class II: Low to moderate risk (e.g., contact lenses, hearing aids)
Class III: Moderate to high risk (e.g., orthopedic implants, blood glucose meters)
Class IV: Highest risk devices (e.g., pacemakers, artificial heart valves)

Canada’s medical device classification system employs a rule-based approach similar to that of Europe, rather than a product list method like Japan. Specifically, classification rules are established based on factors such as the intended use of the medical device, invasiveness, duration of contact with the human body, and presence of energy supply. Each medical device’s class is determined according to these rules. This rule-based approach enables evaluation within the existing classification framework even when new technologies or products emerge.

It is important to note that application requirements and the rigor of review differ according to device classification.

Medical Device Licence (MDL)

To market Class II or higher medical devices in the Canadian market, manufacturers must obtain a Medical Device Licence (MDL). The following documentation is required for application:

Quality Management System Certificate: Certificate demonstrating compliance with ISO 13485 standards
Safety and Efficacy Data: Clinical trial results and non-clinical test data
Labeling Information: Content of product labeling and package inserts
Risk Analysis: Risk assessment and countermeasures associated with device use

More detailed clinical data and safety evaluations are required for Class III and IV devices.

Importantly, Medical Device Licences for Class II, III, and IV devices require an annual licence review. Manufacturers must complete the necessary procedures and pay fees annually to maintain their licences.

Medical Device Establishment Licence (MDEL) and MDSAP

Companies that import or sell medical devices in Canada must obtain a Medical Device Establishment Licence (MDEL). This applies not only to manufacturers but also to importers and distributors. However, facilities that manufacture only Class I devices are exempt from MDEL acquisition.

To obtain an MDEL, the following requirements must be met:

• Implementation of an appropriate quality management system
• Establishment of complaint handling and recall procedures
• Possession of an appropriate record management system

Since January 1, 2019, Health Canada has mandated participation in the Medical Device Single Audit Program (MDSAP) in place of the former Canadian Medical Devices Conformity Assessment System (CMDCAS). This transition was implemented in stages, with 2017 and 2018 serving as transition periods, and only MDSAP certification being accepted after January 1, 2019. While initial participation rates during the transition period were lower than expected (approximately 10% during the pilot phase), Health Canada completed the transition with manufacturers representing over 90% of the medical device industry having submitted transition applications or MDSAP certificates by the January 1, 2019 transition deadline.

Canada has a population of approximately 40 million people and is not necessarily considered a large medical device market. However, with MDSAP mandated, companies exporting medical devices to Canada must invest cost and effort disproportionate to the market size to obtain MDSAP certification. This point may constitute a barrier to entry, particularly for small and medium-sized enterprises.

Special Access Programme (SAP)

Even for unapproved medical devices, there exists a Special Access Programme (SAP) to respond to urgent medical needs. This is a system that provides limited access to devices that have not undergone the normal approval process for patients in life-threatening situations or with serious diseases.

Post-Market Surveillance

In Canada, the following post-market surveillance systems are established to continuously ensure the safety of medical devices on the market:

Adverse Event Reporting: Serious adverse events must be reported within 10 calendar days of becoming aware of the incident, while other adverse events must be reported within 30 calendar days. (The “awareness date” is considered day zero, and the reporting timeframe begins from the day after this date. It is recommended to verify the latest Health Canada guidance for specific deadlines.)

Problem Solving Report (PSR): Documentation of safety-related problems and their solutions
Recall Reporting: Reporting on the implementation of recalls and their progress

It should be noted that these reporting requirements apply to both manufacturers and importers. Health Canada’s incident reporting guidance provides detailed criteria for reportable events and specifies that preliminary reports must be submitted within the above timeframes, followed by final reports once investigations are complete.

Requirements for Foreign Manufacturers

One important characteristic of Canada’s medical device regulations is that they do not mandate the appointment of a Canadian Representative for foreign manufacturers. This contrasts with many countries and regions, such as the European Union (EU MDR), China, and Brazil, where domestic representatives are required.

Due to this regulatory feature, foreign companies can apply directly for a Medical Device Licence (MDL) without having a physical presence or legal representative in Canada. However, in practice, utilizing consultants or representatives familiar with the local regulatory environment often facilitates smoother application procedures and post-market responses.

Additionally, foreign manufacturers are required to submit quality management system certificates (such as ISO 13485 certification) when applying for MDL, and since January 2019, MDSAP certification has been mandatory.

Comparison with Japanese Regulations

Canada’s medical device regulations have similarities to Japan’s Pharmaceutical and Medical Device Act (PMD Act) regulations, but important differences also exist.

Both countries adopt risk-based classification systems, but there are significant differences in classification methods. Japan adopts a “list method” for classifying medical devices, where classification is determined based on specific product names or general names. In contrast, Canada employs a “rule-based method” similar to Europe, where devices are classified according to classification rules based on medical device characteristics (invasiveness, duration of use, energy supply, etc.).

Aspect	Canada	Japan
Classification Method	Rule-based (similar to EU)	List-based (product-specific)
QMS Standard	ISO 13485 strongly emphasized	ISO 13485 adoption varies
Regulatory Approval Concept	“Licence” system	“Approval” system
Manufacturing Authorization	Single MDEL framework	Distinction between marketing authorization holder and manufacturer
MDSAP Requirement	Mandatory since 2019	Voluntary (participating country)
Canadian Representative	Not required	Similar concept (not applicable domestically)

Other main differences include:

• Canada strongly emphasizes ISO 13485 certification as the quality management system
• In Japan, the concept is “approval,” whereas in Canada it is positioned as a “licence”
• Japan distinguishes between marketing authorization holders and manufacturers, while Canada manages both under the single framework of MDEL
• While Canada has mandated MDSAP since 2019, Japan is an MDSAP participating country but participation remains voluntary

Recent Regulatory Developments

In recent years, Canada has been advancing efforts to modernize medical device regulations. Specifically, the following developments are occurring:

Utilization of Real-World Evidence: Introduction of evaluation methods utilizing real-world clinical data

Strengthening International Harmonization: With the complete mandatory implementation of MDSAP from 2019, Canada has completed the transition to an international audit program. This promotes regulatory harmonization with participating countries including the United States, Brazil, Australia, and Japan.

Response to AI and Software Medical Devices: Development of regulatory frameworks for medical devices using artificial intelligence. Health Canada released “Pre-market guidance for machine learning-enabled medical devices” in February 2025, providing specific guidance for AI-enabled devices. Additionally, “Transparency for machine learning-enabled medical devices: Guiding principles” (June 2024) and “Predetermined change control plans for machine learning-enabled medical devices: Guiding principles” (October 2023) were published, establishing a comprehensive framework for AI medical devices.

Review of MDEL Framework: Health Canada is working on modernizing the Medical Device Establishment Licence (MDEL) framework, with considerations including streamlining the application process and improving surveillance methods.

Flexible Licensing Approach: Consideration of flexible regulatory approaches to support rapid market introduction of new medical technologies

Phase I Regulatory Amendments (December 2024): On December 14, 2024, Phase I amendments to the Medical Devices Regulations came into force. These amendments include:

• Improved recall procedures
• New ministerial powers to impose terms and conditions on MDELs
• Enhanced finished product testing requirements

Terms and Conditions for Medical Devices (Effective January 2026): Health Canada has expanded its authority to impose terms and conditions (T&Cs) on Class II, III, and IV medical device licences, effective January 1, 2026. T&Cs can be used to optimize benefits and manage risks and uncertainties associated with medical devices, providing Health Canada with greater flexibility in regulatory oversight.

Phase II Regulatory Amendments (Proposed November 2025): Health Canada proposed Phase II amendments to the Medical Devices Regulations in November 2025, focusing on:

• Modernization of the MDEL framework
• Clarification of uncertainties around medical device importation
• Improved regulatory oversight of the medical device supply chain
• Removal of MDEL requirements for foreign distributors when their Canadian importer already holds an MDEL

Recall Reporting Modernization: Canada is proposing to eliminate mandatory reporting of Type III recalls (products unlikely to cause adverse health consequences), aligning with international standards and allowing Health Canada to focus on more critical recalls.

Guidance on Medical Device Application Types: In August 2025, Health Canada released guidance for determining medical device application types, providing manufacturers with clarity on whether their medical devices (including components and parts) can be combined and submitted as a single device licence or authorization application.

These recent developments demonstrate Canada’s commitment to maintaining a modern, agile regulatory framework that balances patient safety with innovation and international harmonization. The regulatory landscape continues to evolve with consultation periods and stakeholder engagement processes ongoing throughout 2025 and into 2026.