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.
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:
- the removal of information specific to Investigational Testing Authorizations (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.