Notice: Revisions to the Guidance Document: Management of Applications for Medical Device Licences

May 29, 2019
Our file number: 19-110037-653
Health Canada has revised the guidance document titled "Management of Applications for Medical Device Licences". This document outlines the way in which Health Canada manages applications for medical device licences.

This updated version is now in line with the Department's Good Guidance Practices and includes the following key changes: the removal of information specific to Investigational Testing Authorizations (this information is now available in Applications for Medical Device Investigational Testing Authorizations Guidance Document - Summary); additional information regarding Private Label Licence Applications (new and amendments); and, a streamlined appeal process with the removal of the requirement for a letter of intent to appeal.

This guidance document 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, and
• Licence Amendment Minor Changes  (Faxbacks) for Class II, III and IV medical devices
• New and Amendment Medical Device Licence Applications for Private Labels

For guidance on a specific device, please contact the Medical Devices Bureau by email at meddevices-instrumentsmed@hc-sc.gc.ca .

This guidance document comes into effect immediately. Questions or concerns related to this guidance document should be directed to:

Medical Devices Bureau
Health Canada
11 Holland Avenue, Tower A
Address Locator: 3002A
Ottawa, Ontario
K1A 0K9
E-mail: at meddevices-instrumentsmed@hc-sc.gc.ca
Telephone: (613) 957-7285