<h1 class="entry-title">Category: Canadian Licencing</h1>

Design & Development Includes Regulatory Submissions

April 18, 2023 Design & Development Includes Regulatory Submissions   Premarket regulatory submissions [e.g., U.S. FDA 510(k) / PMA; European Technical Documentation Submissions, Canadian Device Licensing, Australian ARTG registration, etc.] need to be driven by, and documented in association with, the design and development process and documentation.  For example, both the FDA (via the QS […]

Health Canada: Licence Amendment vs New Licence Application

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 […]