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January 10, 2026
Approximately 5 minutes
Canada’s Participation in the International Medical Device Regulators Forum (IMDRF)
Canada’s Participation in the International Medical Device Regulators Forum (IMDRF)
Overview of IMDRF
The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from ten founding member countries, established in 2011 as the successor to the Global Harmonization Task Force (GHTF). Its primary objective is to accelerate international regulatory convergence by developing harmonized technical requirements, guidance documents, and common frameworks for medical device regulation. IMDRF membership includes regulators from Australia, Brazil, Canada, China, European Union, Japan, Russia, Singapore, South Korea, the United Kingdom, and the United States (as observers or full members depending on status). Source: Guidance Document: International Medical Device Regulators Forum - Canada.ca
Health Canada’s Role and Engagement
Health Canada is a founding and active member of IMDRF, contributing to working groups, management committee activities, and the development of key IMDRF documents. Canada participates in all major IMDRF work items, including:
- Adverse Event Terminology and Reporting
- Unique Device Identification (UDI) implementation
- Software as a Medical Device (SaMD) classification and cybersecurity
- Personalized medical devices and 3D printing
- Post-market surveillance and vigilance harmonization
Health Canada incorporates IMDRF guidance into its own regulatory framework where appropriate, helping align Canadian requirements with international best practices.
Key IMDRF Achievements and Documents
IMDRF has produced numerous harmonized guidance documents adopted or referenced by member regulators, including:
- IMDRF/GRRP WG/N47 – Essential Principles of Safety and Performance
- IMDRF/SaMD WG/N10 – Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations
- IMDRF/UDI WG/N48 – Unique Device Identification System for Medical Devices
- IMDRF/AE WG/N43 – Adverse Event Terminology
These documents support global consistency in classification, labelling, clinical evaluation, and post-market activities. Health Canada frequently references IMDRF outputs in its own guidance documents for manufacturers.
Benefits for Canadian Stakeholders
Canada’s IMDRF participation facilitates:
- Reduced regulatory duplication for manufacturers seeking multi-country approvals
- Improved access to innovative devices through harmonized requirements
- Enhanced post-market safety monitoring via shared adverse event data and terminology
- Alignment of Canadian standards with major markets (EU, US, Japan, etc.)
Ongoing and Future Priorities
Health Canada continues to support IMDRF initiatives on emerging technologies such as AI/ML-enabled devices, cybersecurity, and regenerative medicine products. The agency also contributes to IMDRF efforts to strengthen international cooperation on supply chain resilience and counterfeit device prevention.
For the most current IMDRF documents, membership updates, and meeting outcomes, refer to the official IMDRF website and Health Canada’s dedicated IMDRF page. Source: Guidance Document: International Medical Device Regulators Forum - Canada.ca
This overview highlights Canada’s commitment to global regulatory harmonization through IMDRF, supporting safer and faster patient access to medical technologies worldwide.
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