Canada – Guidance on terms and conditions for class II to IV medical devices

This guidance document will come into force on January 1, 2026.

The Food and Drugs Act (FDA) and its regulations give Health Canada the authority to regulate food, drugs (including natural health products), medical devices and cosmetics. Our role as a regulator is to verify that regulatory requirements for the safety and effectiveness of medical devices are met. We do this through a combination of pre-market scrutiny, post-market surveillance and compliance and enforcement activities.

The MDR uses a risk-based approach to regulating medical devices. The safety and effectiveness evidence required by these regulations to support a licence application is in proportion to the risk presented by the device.

This approach balances 2 needs:

  • the need to provide people in Canada with timely access to new and innovative technology
  • the need for appropriate levels of pre-market oversight of safety and effectiveness evidence

Since 1998, under section 36 of the MDR, Health Canada may impose T&Cs on a Class II to IV medical device licence. T&Cs are used as regulatory tools to help ensure that medical devices in Canada continue to meet the safety and effectiveness requirements outlined in sections 10 to 20 of the MDR.