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Schedule 1 — Safety and Effectiveness Requirements

What Schedule 1 does​

Schedule 1 sets out the mandatory Safety and Effectiveness Requirements that all medical devices sold in Canada must meet. It is the Canadian equivalent of the EU's GSPR (Annex I of MDR/IVDR) and Australia's Essential Principles.

Structure of Schedule 1​

Schedule 1 is divided into two Parts:

Part 1 — General requirements​

Requirements that apply to all medical devices regardless of type.

Key requirements include:

  1. Devices must be safe and effective for their intended use
  2. The benefits must outweigh the risks
  3. Devices must perform as intended over their expected service life
  4. Devices must not compromise the safety of other devices or substances used with them
  5. Chemical, physical, and biological properties must not pose unacceptable risks
  6. Devices must be designed to minimise infection risk
  7. Devices with a measuring function must be accurate
  8. Devices emitting radiation must limit emissions to the minimum necessary

Part 2 — Specific requirements​

Requirements that apply only to specific device types:

  • Devices with measuring functions
  • Devices connected to a source of ionising radiation
  • Devices incorporating software
  • Active implantable devices
  • Devices intended to be sterilised
  • Devices intended to be implanted in the body

How compliance is demonstrated​

See Overview — Schedule 1 Requirements for the full explanation of how manufacturers demonstrate compliance by device class.

Official source

Medical Devices Regulations, SOR/98-282, Schedule 1