Welcome to the Canadian Medical Device Market

Dive into Canada’s thriving medical devices market, where innovation meets the highest standards of safety and quality. In this dynamic sector, Health Canada ensures that every medical device, from the simplest to the most complex, adheres to stringent regulations under the Medical Devices Regulations (SOR/98-282). A pivotal aspect of navigating these regulations is the Medical Device Single Audit Program (MDSAP), the only recognized pathway for manufacturers to demonstrate compliance with Canada’s quality requirements.

The MDSAP is a groundbreaking initiative that allows a single regulatory audit to satisfy the requirements of multiple jurisdictions, including Canada. This program simplifies the approval process for medical devices, ensuring they meet the rigorous standards for safety and effectiveness before reaching the Canadian market. Since January 1, 2019, MDSAP has become mandatory for manufacturers of class II, III, and IV medical devices in Canada, marking a significant shift towards streamlined and efficient regulatory oversight.

Whether you’re a healthcare provider, innovator, or consumer, understanding the MDSAP and its role in the Canadian medical devices market is crucial. This market not only champions innovation but also ensures that every device contributes positively to healthcare outcomes across Canada. With a focus on quality, safety, and regulatory compliance, Canada’s medical devices sector stands as a testament to the country’s commitment to health and wellness.

Registration Process

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Health Canada Assessment

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Our Services


Regulatory Affairs Support

Offering full-spectrum regulatory expertise in Canada’s medical device sector, from gap analysis to Health Canada submissions and continuous support, ensuring seamless compliance and market success.

Quality Management

Quality Management Support

Sobel Consultancy’s Quality Management Support offers unparalleled assistance in harmonizing your existing quality management system with the requirements of the MDSAP related to Health Canada.

Risk Management

Manage medical device risks effectively with ISO 14971-based Risk Management Support. Expert planning, comprehensive risk analysis, and effective control measures are at your disposal. A final report evaluates overall risk, ensuring safety and compliance.


Biological Evaluation

Specializing in ISO 10993-compliant biological evaluations, we ensure your medical devices meet global safety and regulatory standards, enhancing market approval chances. Expert analysis for biocompatibility, toxicological risk assessment, and regulatory success.

Clinical Evaluation

Specialized service in crafting comprehensive clinical evaluations for medical devices targeting the Canadian market, fully aligned with Health Canada’s rigorous regulatory framework to facilitate seamless market entry and approval processes.

Submission File Elaboration

Expertise in assembling Health Canada submission files for medical devices, ensuring full compliance with Canadian Medical Devices Regulations (CMDR) for efficient market entry and approval. Tailored guidance through every step of the regulatory process.


Elevate your expertise in the Canadian medical device market with our targeted training programs. Tailored to align with Health Canada’s regulations, our courses cover everything from the basics of Canadian Medical Devices Regulations (CMDR). Ensure your success in compliance and market readiness with training that meets the industry’s highest standards.

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