Regulatory Open Forum

Hi Folks, 

Our company holds a system license in Canada. Is it permissible to submit multiple amendments simultaneously? or we are required to wait until the pending amendment has a result?

Thank you very much for your attention, 

Linda 

Yes depending on the nature of the change(s) and the device class.  For example, significant change amendment packages for class III and IV devices may encompass multiple changes.  Similarly, the Licence Amendment Fax-Back Form for Non-Significant Additions/Deletions of Catalogue Numbers Only permits multiple changes to be made therein. By contrast, the Fax-Back amendment form for changing the license name is limited only to that change.  So the specific details of your scenario would need to be better understood to give a proper answer.

But for practical intents and purposes, it could cause processing problems if multiple amendment applications are submitted at the same time (such as more than one significant change amendment application).  In such a scenario, I would first establish an understanding with Health Canada's license amendment folks before attempting to submit multiple applications at once.

Hi Folks, 

Our company holds a system license in Canada. Is it permissible to submit multiple amendments simultaneously? or we are required to wait until the pending amendment has a result?

Thank you very much for your attention, 

Linda