Permanent framework for COVID-19 medical devices

Summary#

The final rule, the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19), adds a new Part 1.1 to the Medical Devices Regulations to create a permanent framework for COVID-19 devices. It carries over authorizations issued under Interim Order No. 3 (more than 800 devices), keeps many of the faster access rules, and adds longer‑term oversight and reporting requirements. The instrument was registered February 3, 2023 and published February 15, 2023.

What it does#

• Creates a new Part 1.1 in the Medical Devices Regulations specifically for COVID-19 medical devices.
• Converts existing authorizations issued under Interim Order No. 3 into authorizations under Part 1.1 so those devices can still be imported and sold.
• Requires the government to publish a List of Medical Devices for an Urgent Public Health Need (the “UPHN list”) and uses that list to decide which devices keep the temporary flexibilities.
• Keeps many interim flexibilities while a device is on the UPHN list (for example, some usual licensing and quality‑management requirements are relaxed).
• Sets a permanent expedited authorization pathway and allows “expanded uses” and recognition of approvals from trusted foreign regulatory agencies for urgent COVID‑19 needs.
• Raises certain application and evidence requirements, including asking for proof a quality management system exists for manufacturers (with timing differences depending on device class).
• Adds or clarifies post‑market obligations:
  • Incident reporting: preliminary report within 10 days for events causing death or serious deterioration; 30 days for other serious incidents that could recur.
  • Serious‑risk information must be reported within 72 hours after the holder becomes aware of it.
  • Summary safety reports: every 24 months for Class II devices (biennial) and every 12 months for Class III and IV devices (annual).
  • Records must be kept for seven years.
• Sets transition times when a device is removed from the UPHN list:
  • Class I manufacturers have 120 days to apply for an establishment licence (MDEL).
  • Class II–IV manufacturers must show within 120 days they’ve started quality management system certification and have two years to obtain the certificate.
• Allows importers and distributors to sell existing stock for six months after a manufacturer’s authorization is cancelled, subject to labelling and licence rules.
• Comes into force the day after Interim Order No. 3 ceases to have effect (or on registration if registered later).

Who's affected#

• Manufacturers of COVID‑19 medical devices (both Canadian and foreign) — especially those who received authorizations under the interim order.
• Importers and distributors, who must hold or use a medical device establishment licence and follow post‑market reporting and record rules.
• Hospitals and health facilities, which will continue to report incidents involving these devices.
• Patients and health‑care providers who rely on COVID‑19 devices such as test kits, personal protective equipment, ventilators, syringes and related supplies.
• Small businesses: many firms that used the interim order pathway are small and may keep easier market access while a device remains on the UPHN list.
• Health Canada, which will manage the UPHN list, applications, and ongoing oversight (the department estimated incremental enforcement costs of about $42,000 per year in its analysis).

If anything is unclear from the source: the exact timing of the Regulations’ coming into force depends on when Interim Order No. 3 ends, and the UPHN list will be updated over time, so which devices keep flexibilities can change.

Why it matters#

• It avoids a sudden loss of access to vital COVID‑19 medical devices that were approved under the emergency interim order — affecting more than 800 devices — which could otherwise have become unavailable when the interim order expired (noted as February 21, 2023 in planning documents).
• It gives manufacturers a stable, permanent pathway for fast access during urgent public‑health needs, while adding steps (quality systems, annual/biennial safety reviews, incident reporting) to protect patients as devices move out of emergency status.
• Health‑care systems, pharmacies and supply chains get predictability: import, sale and labelling rules are clarified, and importers must include a copy of the device authorization with shipments.
• Small manufacturers and importers keep a lower‑cost route to market while the device is on the UPHN list, but may face extra costs and certification steps if they want to continue selling once the urgent‑need designation is removed.