Regulatory Open Forum

Hi there,

The Health Canada Class IV Medical Device License application form has drop down options for Application Types (with different pre-populated fees). "Changes in Manufacturing" and "significant changes (not related to manufacturing)" are listed as different Application Types. Is it possible to submit a single license amendment to include both types changes (and select the Application Type option with the higher application fee), or do I need to submit them in series instead (in separate license amendments)?

Thanks for your guidance!

One amendment application form, but two fee forms.  I explain further below:

For a Health Canada Class IV 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, bundle multiple types of changes (e.g., manufacturing changes plus significant changes not related to manufacturing) by checking all of the applicable boxes and  including the corresponding supporting documentation.

But the Fee Form and its drop-down menu to which you refer only allows you to select one type of amendment and calculate the fee for that particular aspect.  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.

Hi there,

The Health Canada Class IV Medical Device License application form has drop down options for Application Types (with different pre-populated fees). "Changes in Manufacturing" and "significant changes (not related to manufacturing)" are listed as different Application Types. Is it possible to submit a single license amendment to include both types changes (and select the Application Type option with the higher application fee), or do I need to submit them in series instead (in separate license amendments)?

Thanks for your guidance!

One amendment application form, but two fee forms.  I explain further below:

For a Health Canada Class IV 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, bundle multiple types of changes (e.g., manufacturing changes plus significant changes not related to manufacturing) by checking all of the applicable boxes and  including the corresponding supporting documentation.

But the Fee Form and its drop-down menu to which you refer only allows you to select one type of amendment and calculate the fee for that particular aspect.  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.

Hi there,

The Health Canada Class IV Medical Device License application form has drop down options for Application Types (with different pre-populated fees). "Changes in Manufacturing" and "significant changes (not related to manufacturing)" are listed as different Application Types. Is it possible to submit a single license amendment to include both types changes (and select the Application Type option with the higher application fee), or do I need to submit them in series instead (in separate license amendments)?

Thanks for your guidance!