On May 29, 2019, the Canadian regulatory Authority issued the updated version of the “Guidance Document: Management of Applications for Medical Device Licences”, which outlines the way in which Health Canada manages applications for medical device licences.

CANADA: Transparency in the medical device screening process: Health Canada revises the Guidance Document

The guidance, in line with the Department’s current Good Guidance Practices, applies to the following application types:

  • Licence Applications for Class II, III and IV Medical Devices;
  • Licence Amendments for Class II Medical Devices, and Licence Amendments (significant changes) for Class III and IV Medical Devices;
  • Licence Amendment Minor Changes (Faxbacks) for Class II, III and IV Medical Devices;
  • New and Amendment Medical Device Licence Applications for Private Labels.

Coming into effect immediately, the document includes the following key changes:

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