Your Gateway to North America's Growing Healthcare Market

Canada, with its population of over 38 million, relies heavily on imports to meet approximately 70% of its domestic demand for medical devices. The country's medical device sector is witnessing a surge in demand, fueled by an increase in chronic diseases and an aging population. This presents a significant opportunity for global medical device manufacturers.

Device Classification and Regulatory Pathways

Complying with Canadian Regulations

Regulatory Authority

In Canada, the Food and Drugs Act along with the Medical Device Regulations govern all medical devices. Health Canada is the regulatory body tasked with reviewing medical devices to ensure their safety, effectiveness, and quality. Approval from Health Canada is mandatory before any medical device can be marketed in Canada.


Canada categorizes medical devices into four classes based on the risk they pose. This classification influences the regulatory requirements for approval:

  • Class I devices, considered low risk, require a Medical Device Establishment License (MDEL) for manufacturers or importers.
  • Class II, III, and IV devices, representing higher risk levels, must obtain a Canadian Medical Device License (MDL) and undergo certification through the Medical Device Single Audit Program (MDSAP).

Key Requirements

The path to market involves:

  • Classifying your product correctly.
  • Obtaining an MDEL for Class I devices or an MDL for Classes II to IV devices.
  • Undergoing MDSAP certification for Class II to IV devices.

Foreign manufacturers benefit from not having to appoint a local license holder, streamlining the process for market entry.

How We Can Help

Tailored Support for Market Entry

We offer comprehensive support to streamline your market access in Canada:

  • Classifying and grouping your products to define the regulatory pathway.

  • Assisting with the compilation of the technical dossier for MDL or MDEL applications.

  • Guiding you through the MDL or MDEL application process to ensure compliance with Health Canada's requirements.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.

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