Canada
Canada is one of the most regulated and technologically advanced markets for medical devices, with a strong demand for innovative products, particularly in the public healthcare sector. The market is characterized by stringent safety and quality standards, enforced by Health Canada regulations.
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Contact us! We are happy to advise you:
Regulatory Framework
The competent authority for the regulation of medical devices in Canada is Health Canada - Medical Devices Bureau (MDB).
Device classification:
- Class I: Low risk
- Class II: Moderate risk
- Class III: High risk
- Class IV: Very high risk
Specific Local Requirements
| Language | Documentation must be in English or French. |
| Certifications | MDSAP (Medical Device Single Audit Program) certification is required for Class II, III, and IV devices. Class I devices are exempt but must still comply with Health Canada's quality and safety standards. |
| Licences | Medical Devices Active Licence (MDALL): Required to import Class II, III, and IV medical devices.
Medical Device Establishment Licence (MDEL): Required to import Class I medical devices. |
Challenges and Operational Advice
- Strict regulations: Health Canada enforces highly detailed approval processes and requires strong compliance with international standards.
- MDSAP requirement: Mandatory for selling Class II, III, and IV devices on the Canadian market.
- Renewal process: Annual.
Why Choose ISEMED
- North America expertise
Comprehensive assistance with the Health Canada registration process. - MDSAP support
Help with certification, preparatory audits, and relationship management with Health Canada. - Digital certification management
Support in complying with Digital Health Certificate requirements for IoT devices.
FAQ
- Is a local representative required? No.
- Documentation language? English or French.
- Licence duration? Annual renewal.