Canada Medical Device and IVD Quality Watch: January 2026

For Canada, ongoing compliance is as important as the initial licence pathway. Manufacturers should maintain a reliable link between the product licence, quality system evidence, complaint handling, and significant change assessment.

What to review

• Device classification and medical device licence data for each marketed product.
• Quality management system evidence, supplier controls, and document-change governance.
• Complaint handling, incident reporting, recall readiness, and evidence for licence amendments where required.

Practical impact

A controlled portfolio register allows teams to identify which changes affect product licences, labels, manufacturing sites, or technical documentation. This is particularly useful for IVD portfolios with frequent assay, software, or labelling updates.

Source to monitor

Monitor Health Canada medical devices for current licence and compliance guidance.