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:

1. Class IV Medical Device Licence Amendent Application Form

2. 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.

In the end, Health Canada will in due course calculate and, as needed, adjust, the ultimate fee invoice accordingly based on the scope of the amendment.