March 9, 2023
Health Canada: Licence Amendment vs New Licence Application
Knowing whether an existing Canadian Medical Device Licence can be amended or an entirely new Medical Device Licence is required depends on a number of critical factors/variables. Those critical factors/variables include, but may not be limited to, the licence/device class, licence type, and the specifics of the change. Those details need to be known in order to unravel and apply Health Canada’s corresponding licence amendment requirements.
Some changes can be made via relatively abbreviated amendments using an abbreviated mechanism/format offered by Health Canada, while other amendments need a full amendment using Health Canada’s full amendment format, while still other changes will indeed demand a whole new licence application altogether. These amendment variables aren’t driven by the manner in which you keep your internal technical documentation or file; instead, they are driven by the nature of the variables themselves.