February 24, 2023
Health Canada Class IV Device Licence Amendment and Fee Forms
For a Health Canada Class IV medical device licence amendment, there are generally two types of forms needed:
Class IV Medical Device Licence Amendent Application Form
Medical Device Application Fee Form
On the Application Form, we can bundle multiple types of changes (e.g., classification, manufacturing, design/performance, labelling, materials, etc., etc.) by checking all of the applicable boxes and including the corresponding supporting documentation.
But the Fee Form and its drop-down menu only allows us to select one type of amendment and calculate the fee for that particular aspect. But since the applicable fee regulations (e.g., SOR/2019-124) are intended for Health Canada to collect all fees applicable depending on the full scope of the amendment, then I complete a separate fee form for each type of triggering amendment.
So the overall application package would include one Application Form supported by the fee form (or forms) needed to cover the various fees for all of the triggering billable changes in the amendment.