UPHN Device Authorization under Part 1.1

1. Key takeaways

Devices needed for urgent public health needs (UPHN) are admitted under Part 1.1 of the Medical Devices Regulations in the form of an authorisation. According to Health Canada, amendments effective from January 3, 2024 extended the scope of Part 1.1 to other public health emergencies beyond its original application. Authorisation holders must fulfil post-market obligations including distribution records, complaint handling, incident reporting and recalls. The pathway is legally distinct from the MDL, but its safety obligations are deliberately aligned with the ordinary regime: the same 10-day and 30-day reporting tiers apply, and the complaint handling requirements were introduced precisely to close a gap that had existed under the earlier interim orders.

• UPHN devices enter through a Part 1.1 authorisation, a route parallel to MDL licensing.
• From 2024-01-03, Part 1.1 applies to other public health emergencies as well.
• Authorisation holders report events within 10 days (death or serious deterioration in health) or 30 days (not resulted, but might if it recurred).
• Importers must comply with Sections 59–61 reporting under Section 68.03(2)(a); hospitals report under Section 62 via Section 68.03(2)(c).
• UPHN devices are not subject to the annual fee for the right to sell.

2. Legal basis

The table below lists the sources for the UPHN pathway: the scope extension of Part 1.1, the reporting duties placed on importers and hospitals, the reporting timelines for authorisation holders, and the fee provision that excludes UPHN devices from the annual fee.

3. Expert insights

Insight 1: UPHN is an authorisation, not a licence — the legal paths differ.

UPHN follows the authorisation path of Part 1.1, running parallel to the licensing path of the MDL. The fee order expresses the two separately: the wording refers side by side to devices that are “licensed” and devices that are “authorized”. The distinction is not merely linguistic. A licence under the ordinary pathway and an authorisation under Part 1.1 arise from different provisions, carry different conditions, and end differently. Companies operating in this space should keep the two tracks conceptually separate, because the obligations and the fee treatment attach to the form of the authorisation itself, and documents that blur the two risk misstating both.

Insight 2: UPHN devices are exempt from the annual fee for the right to sell.

Under Section 77(1) of the Order Respecting Fees for Drugs and Medical Devices, the annual fee for the right to sell applies to “licensed Class II, III or IV devices, or authorized Class II, III or IV devices that are not UPHN devices”. Read in reverse, this means the annual fee does not apply to UPHN devices. The exemption is a matter of the fee schedule’s own wording, so the correct budgeting approach is simply to leave the line item out for UPHN authorisations — while still accounting for any other fees that apply to the project under their own provisions.

Insight 3: The event reporting timelines for authorisation holders are the same as the ordinary ones.

According to Health Canada’s explanation, an authorisation holder must report all events occurring in Canada: within 10 days of becoming aware of an event that resulted in death or a serious deterioration in health, and within 30 days for an event that has not done so but might, if it recurred, lead to such outcomes. Importers must comply with Sections 59–61 under Section 68.03(2)(a), and hospitals must report under Section 62 pursuant to Section 68.03(2)(c), submitting a written report within 30 days after a serious device incident is documented. The UPHN framework therefore reuses the ordinary reporting architecture rather than inventing a lighter one, and processes built for MDL holders transfer to this pathway with little adaptation.

Insight 4: Complaint handling is an item specifically completed within the UPHN framework.

According to Health Canada’s explanation, the complaint handling requirements were introduced to close a gap in the chapters that applied under the earlier interim order (IO No. 3): the original requirements established a documented procedure for handling complaints but did not set out explicit complaint handling requirements. Authorisation holders, importers and distributors must all satisfy the post-market requirements relating to complaint handling. The lesson for compliance planning is that the existence of a written procedure is not the endpoint — the substantive requirements now apply, and each party in the distribution chain carries them.

4. Practical recommendations

• Determine whether the Part 1.1 authorisation pathway applies, and confirm the status of the public health emergency determination.
• Authorisation holders should build event reporting processes on the 10-day / 30-day tiers, consistent with ordinary MDL holders.
• Importers should configure the capacity to report under Sections 59–61 in accordance with Section 68.03(2)(a).
• Authorisation holders, importers and distributors should all implement the complaint handling requirements — not limited to procedure documents.
• Do not include the annual fee for the right to sell for UPHN devices in the budget (not applicable), but account for other fees according to their applicable provisions.

5. Verification checklist

• □ It has been determined whether the Part 1.1 UPHN authorisation pathway applies
• □ The authorisation holder has built event reporting processes on the 10-day / 30-day tiers
• □ The importer has configured the capacity to report under Sections 59–61
• □ Authorisation holders, importers and distributors have all implemented the complaint handling requirements (including the substantive requirements)
• □ UPHN devices have not been included in the annual fee budget for the right to sell (not applicable)
• □ Distribution records and recall procedures have been established

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Canadian market. Our team manages Health Canada Medical Device Licence and MDEL applications, prepares risk-classified dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com