How to Register a Medical Device in Canada

This video gives you a complete, practical overview of how to register a medical device with Health Canada, the authority responsible for regulating medical technologies in Canada. It walks you through every step of the Canadian Medical Devices Regulations (CMDR) process, starting with risk classification and appointment of a Canadian regulatory representative, through preparation of your technical documentation, and ending with submission for a Medical Device Licence (MDL). If you are looking to enter or expand in the Canadian market, this is the roadmap to doing it right the first time.

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Topics covered in this video include:

• An overview of Canada’s medical device market dynamics and growth drivers
• Device classification and how it affects your licensing pathway
• Key documentation and submission requirements under CMDR
• The role of MDSAP audits in maintaining market access
• How Pure Global accelerates Health Canada approval

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Canada represents one of the most attractive medical device markets in the world. With a population of 38 million and nearly 70% of devices imported, the $9.47 billion market is growing at a steady 6.3% CAGR. An aging population (19% of Canadians are over 65) and the country’s high standards for care are driving demand for advanced technologies that address chronic diseases and modernize healthcare delivery. For manufacturers, gaining Health Canada approval through the CMDR is the key to tapping into this demand and building a presence in a stable, high-value market.

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The Canadian system uses a four-tier, risk-based classification (Class I–IV), which determines whether your device requires a Medical Device Establishment Licence (MDEL) or a Medical Device Licence (MDL), as well as the level of evidence and documentation needed. Class I devices are low-risk and require only an MDEL, while Class II, III, and IV devices require MDLs with increasingly stringent evidence requirements, including compliance with the Medical Device Single Audit Program (MDSAP) for quality systems. Foreign manufacturers must also appoint a Canadian regulatory representative to serve as the official liaison with Health Canada.

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Need CMDR approval?
Pure Global’s team of regulatory specialists streamlines every stage of the Canadian registration process, from classification and licensing to audit readiness and post-market compliance. Our expertise helps you reduce risk, shorten timelines, and achieve a seamless entry into Canada’s fast-growing medtech market. Contact us to learn more about Canadian medical device registration.

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