Updates to the medical device establishment licence application (FRM-0292) and instructions
Administrative update to medical device establishment licence application forms and guidance instructions. Changes improve the application process for medical device manufacturers and establishments.
📅 Effective / published: 2023-12-04
Manufacturers and sponsors placing medical devices on the Canada market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗