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Regulatory News: Health Canada Releases New Guidance on Medical Device Regulation

Health Canada has published three key updates: 

  1. Guidance on medical device establishment licensing (GUI-0016). 
  2. Draft Guidance for determining medical device application type
  3. Draft Guidance for Machine Learning-Enabled Devices 

First, on September 6, 2023, Health Canada's Regulatory Operations and Enforcement Branch revised the guidance on regulatory requirements in relation to the medical device establishment licence (MDEL).


  • Incorporated the applicable sections of paragraphs 45 (h) and 45 (h.1) in the amended Medical Device Regulations (MDR)
  • Introduced sections 62.21 to 62.26
  • Aligned an MDEL requirement with the MDR
  • Clarified various sections of the document including submitting MDEL amendments

View the revised guide HERE. 

Second, Health Canada wants to ensure that manufacturers have the necessary guidance to determine:

  • If their medical devices, including components and parts, can be combined together and submitted as 1 device application
  • The application type as a medical device family, medical device group, medical device group family, system, test kit, or single
  • This will help manufacturers submit the information that is specified in section 32 of the regulations or, if applicable, section 68.11 of the regulations. This allows Health Canada to assess the safety, quality, and effectiveness of a medical device.

Devices that don't fit into these combinations must be individually licensed or authorized under relevant sections of the regulations and are referred to as "single medical devices" in this document.

Find out more about the scope of the guide HERE.

Third, On August 30, 2023, Health Canada issued draft pre-market guidance for machine learning-enabled medical devices (MLMDs). This guidance outlines key considerations and best practices for demonstrating the safety and effectiveness of MLMDs throughout their lifecycle, including design, risk management, data handling, development, testing, clinical validation, transparency, and post-market monitoring.
Read the press release and full guidance HERE. 

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