Updated and new draft Health Canada guidance documents related to medical devices

Smart & Biggar

On August 30, 2023, Health Canada opened consultation on its draft pre-market guidance for machine learning-enabled medical devices (MLMD), i.e., medical devices that use machine learning, in whole or in part, to achieve their intended medical purpose. The guidance assists manufacturers who submit an application for an MLMD, outlines expectations for demonstrating the safety and effectiveness of an MLMD, and introduces a regulatory mechanism for the pre-authorization of planned changes to a MLMD through a pre-determined change control plan (PCCP). Consultation will close on October 29, 2023.

On September 6, 2023, Health Canada updated its guidance on the regulatory requirements for medical device establishment licences (MDEL). Key changes include:

  • Updated examples for MDEL and/or medical device licence requirements and exemptions;
  • Added information for small business fee reductions;
  • Revised timeline to submit amendments outside the annual licence review period;
  • Added the definition for ‘shortage for a medical device’; and
  • Updated section outlining the key responsibilities of an MDEL holder for incident reporting, foreign risk notification for medical devices, and reporting medical device shortages and discontinuations. 

On September 11, 2023, Health Canada opened consultation on its draft guidance for determining medical device application type. The guidance will explain the different application types listed under the Medical Devices Regulations and provide guidance on whether certain medical devices should be combined and submitted as a one device licence or authorization application. Consultation will close on November 10, 2023.

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