Regulatory Open Forum

Hi <g class="gr_ gr_128 gr-alert gr_spell gr_run_anim ContextualSpelling ins-del multiReplace" id="128" data-gr-id="128">Aliva</g>,

Yes, Health Canada enables medical device manufacturers to make changes even after approval of the product. But, based on the level of significance in the changes you intend to make, there are two types of applications that you could submit.

1. Significant - There are various license amendment forms for class II, III and IV if your changes are significant (Intended use, design, manufacturability, changes to instructions for use (Package Insert), the level of risk, an addition of a new size to the range already approved etc.

2. Non-Significant - It is comparatively an easy process where you fill out the non-significant license forms and <g class="gr_ gr_2431 gr-alert gr_gramm gr_run_anim Grammar multiReplace" id="2431" data-gr-id="2431">fax</g> it for approval within less than 2 weeks (or a little longer). The non-significant changes include documentation/ typographical corrections for addresses, <g class="gr_ gr_2866 gr-alert gr_spell gr_run_anim ContextualSpelling" id="2866" data-gr-id="2866">catalogue-part</g> numbers, device names etc. A rationale has to be provided for all the changes being proposed.

The below link has all the information and forms you need to fill out based on your situation. 

Forms - Application Information - Medical Devices - Health Canada

I'd be happy to help you if you may have further questions.