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 […]
<h1 class="entry-title">Category: Canadian Licencing</h1>
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 […]
Health Canada Class IV Device Licence Amendment and Fee Forms
February 24, 2023 Health Canada Class IV Device Licence Amendment and Fee Forms For a Health Canada Class IV medical device licence amendment, there are generally two types of forms needed: Class IV Medical Device Licence Amendent Application Form Medical Device Application Fee Form On the Application Form, we can bundle multiple […]