Familiarize Yourself with Regulations: Review the Medical Devices Regulations (SOR/98-282) and relevant guidance documents from Health Canada to understand the requirements for Class III IVDs.

Implement a post-market surveillance plan to monitor the device's performance in the real world. This includes collecting data on adverse events and user feedback.

ISO 13485: This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

When applying for Class III in vitro diagnostic medical devices (IVDs) Medical Device License (MDL) registration in Canada, you must prepare a range of technical documents. These documents provide evidence of the device's safety, effectiveness, and compliance with regulatory requirements.

Timeframe: Several months to over a year (varies based on device complexity and readiness of documentation).

Confirm that the device is classified as Class III according to Health Canada’s classification rules. Class III devices are considered high-risk and typically require comprehensive evidence of safety and effectiveness.

Confirm that your device is classified as Class III according to Health Canada’s classification criteria.

When preparing for Class III in vitro diagnostic medical devices (IVDs) Medical Device License (MDL) registration in Canada, you'll need to compile various materials and documents.