Reforms Tracker
A running tracker of significant regulatory reforms affecting medical devices in Canada. Status current to May 2026.
Active / in-progress reforms
| Reform | Status | Est. timeline |
|---|---|---|
| UDI framework (final regulations) | Final rule anticipated | 2025–2026 |
| Mandatory PMS requirements (Class III/IV) | Consultation complete; drafting | 2026–2027 |
| SaMD/AI cybersecurity regulations | Guidance published; regulatory amendments in development | 2026 |
| Post-market clinical data requirements | Under development | TBD |
Recently completed reforms
| Reform | Status | Year finalised |
|---|---|---|
| MDSAP formal recognition | Complete — now required for all DL applications | 2019 |
| Mandatory problem reporting amendments | Complete | 2019 |
| SaMD classification guidance | Guidance published (not regulation) | 2023 |
How to track reforms
- Subscribe to Canada Gazette Part I and Part II alerts — covers all proposed and final regulatory changes
- Monitor Health Canada's What's New page — canada.ca/health-canada medical devices announcements
- Engage with MEDEC — Canada's medical device industry association, which actively tracks and engages on regulatory reforms
- Monitor IMDRF outputs — many Canadian regulatory changes follow IMDRF guidance documents
Official source