Canada Updates Exceptional Import Guidance in October 2026: Changes in Foreign Authorization Trigger 72-Hour Reporting

On October 7, 2026, Health Canada published Version 2 of the Guide on the exceptional importation and sale of medical devices in response to shortages (GUI-0147), replacing Version 1 of March 2022. The update makes two substantive changes: it rewrites the criteria for determining which devices may be added to the exceptional importation list and clarifies the boundaries of the framework; and it adds a 72-hour notification obligation. Where the foreign authorization for a designated device lapses, or where no authorization is required but the device may not meet local legal requirements, the licence holder must report to Health Canada within 72 hours of becoming aware. Existing requirements are not removed, including notification at least three business days before importation, quantity limits and cut-off dates listed for the list, and bilingual English and French information.

Published: October 28, 2026, 19:52

Category: Registration and Market Access

Primary sources:

• Health Canada — Guide on the exceptional importation and sale of medical devices in response to shortages (GUI-0147), Version 2: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guide-exceptional-importation-sale-medical-devices-response-shortages-0147.html (October 7, 2026)
• Justice Laws Website — Medical Devices Regulations (SOR/98-282), ss. 62.27–62.323: https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/page-7.html
• Health Canada — List of medical devices for exceptional importation and sale: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/shortages/exceptional-importation-sale.html

1. This Update Changes Two Provisions, Not Just a Principle

On October 7, 2026, Health Canada published Version 2 of the Guide on the exceptional importation and sale of medical devices in response to shortages (GUI-0147), replacing Version 1 of March 2, 2022. The change record is direct and lists only two items: amend the criteria in section 62.28 for adding a device to the exceptional importation and sale list, to explain the scope of the framework; and add section 62.321, requiring notification to Health Canada of changes to the foreign authorization for designated devices.

Both sound like technical details. Operationally, they are not. The first determines whether a product is eligible for this pathway. The second determines what report is still owed after the goods have arrived in Canada.

2. The Pathway Is a Permanent Regime, Not a Pandemic Temporary Measure

The legal basis for the exceptional importation and sale framework is found in sections 62.27 to 62.32 of the Medical Devices Regulations, which became permanent provisions on March 2, 2022. The SOR/2026-96 amendment, effective June 17, 2026, further amended this part, and Version 2 of the guidance was rewritten to follow these amendments.

The framework is clearly positioned: it allows devices that already hold a foreign authorization to fill a gap when Canadian-authorized devices are in shortage. It is not a substitute for registration and does not create a Canadian medical device licence.

3. Eligibility for the List Is Assessed Against Four Conditions

Section 62.28 requires the Minister to add a device to the list only where the following conditions are met:

• There is a shortage or risk of shortage of another device;
• If that shortage occurs, it may present a risk of harm to persons;
• The device proposed for addition can replace the device in shortage;
• The device proposed for addition is authorized for sale by a regulatory authority in its jurisdiction, or, where authorization is not required locally, meets the legal requirements of that jurisdiction.

The second condition is the most easily overlooked. If the shortage is merely a supply inconvenience and does not constitute a risk of harm, the pathway does not apply. The third condition is similar: the substitution must be defensible; use in the same clinical department is not enough by itself.

4. Pre-Import Procedures Remain the Same Three Requirements

Section 62.29 sets out import conditions. The licence holder must notify, in the specified format, at least three business days before the date of importation. The notification must include: the name and contact information of the licence holder; the name of the device and each component, part and accessory, including model where applicable; the device identifier; the name and contact information of the manufacturer as shown on the label; the manufacturing address, if different; a detailed description of the intended use and performance specifications; the intended port of entry; the expected date of arrival; and the quantity intended to be imported.

The list must also already specify the device name, class, manufacturer name, licence number of the holder, name of the corresponding regulatory authority, maximum quantity that may be imported (where applicable), and the date after which the device may no longer be imported. Total imports must not exceed the maximum, and the import date must not be later than that cut-off date. The licence holder must also prepare in advance a plan describing how it will meet the information obligations under section 62.32.

5. Post-Import Obligations Last Longer Than Pre-Import Requirements

Section 62.31 provides a limited exemption: except for a small number of provisions, the other regulations do not apply to the sale of these devices. The exemption has an end point, whichever is earlier: expiry of the device's shelf life, or two years from the cut-off date specified on the list.

The information obligations do not end that early. Section 62.311 requires that, when devices are sold by retail to the public, information such as the intended use be provided to purchasers in English and French. Section 62.32 requires the licence holder to ensure that bilingual English and French information is available and in a manner that supports safe use, continuing until the end of the shelf life or expected useful life of the last batch.

The newly added section 62.321 is the focus of this update: once the licence holder receives or becomes aware that the device is no longer authorized for sale by the regulatory authority listed for the list, or, where authorization is not required, may not meet local legal requirements, the holder must notify Health Canada within 72 hours in the specified format. The clock starts when the holder receives or becomes aware, not when confirmation is complete.

6. The List Is Public and Shows Who Uses This Pathway

The List of medical devices for exceptional importation and sale is public on the Health Canada website. It lists, item by item, the device name and class, manufacturer, licence holder and licence number, source of foreign authorization, date of addition, cut-off date and quantity. The list includes products based on authorization by China's National Medical Products Administration, such as Guangzhou Hypnus's non-invasive ventilator series, with a Canadian licensed importer as the holder.

This illustrates one point: foreign authorization is one of the entry tickets, but the party that applies and bears the notification and information obligations is the Canadian licensed importer, not the foreign manufacturer.

7. Two Further Provisions Are Easily Missed

Section 62.322 provides that section 61.2 applies, with necessary modifications, to the importer that is the licence holder for these devices. The specific obligations under section 61.2 require a provision-by-provision reading of the regulation; the guidance does not elaborate.

Section 62.323 provides that if a device is removed from the list before the information obligation period ends, it continues to be treated as a designated device for the remaining period. In other words, removal from the list does not immediately reduce the obligations to zero.

Sources and Scope of Verification

Sources:

• Health Canada — Guide on the exceptional importation and sale of medical devices in response to shortages (GUI-0147), Version 2, published October 7, 2026: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guide-exceptional-importation-sale-medical-devices-response-shortages-0147.html
• Justice Laws Website — Medical Devices Regulations (SOR/98-282), sections 62.27 to 62.323, including the SOR/2026-96 amendment: https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/page-7.html
• Health Canada — List of medical devices for exceptional importation and sale (public list): https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/shortages/exceptional-importation-sale.html

Verification scope and access date: The three pages above were accessed and checked on October 28, 2026, to confirm the guidance version number, publication date, the two items in the change record, and the current text of sections 62.28, 62.29, 62.31, 62.311, 62.32, 62.321, 62.322 and 62.323 of the Regulations.

Applicability: This article is an interpretation of public regulatory information and does not constitute a conclusion or commitment for any specific product, company or registration application. The guidance is an administrative document; where it conflicts with the law, the law prevails. The application of provisions, notification formats and time limits are subject to the original Health Canada text and specified forms, and the information may change with subsequent official updates.

AIMEILI Regulatory Interpretation

For global medical device manufacturers, distributors, CROs and regulatory affairs teams, the practical significance of GUI-0147 Version 2 is not limited to a new 72-hour clock. It tightens the evidence and communication chain around the exceptional importation pathway. The pathway remains a shortage-response mechanism, not a route to Canadian registration. Eligibility depends on a documented shortage or risk of shortage, a risk of harm, a defensible replacement relationship and a valid foreign authorization or compliance with local legal requirements where no authorization is required.

The 72-hour notification obligation is triggered by receipt of information or awareness, not by final confirmation. Companies should therefore treat foreign authorization status as a controlled regulatory data point. Suspensions, withdrawals, restrictions, non-renewals, changes in regulatory authority status and signals that a device may not meet local legal requirements should be escalated promptly to the Canadian licence holder so that a notification can be assessed and, where required, submitted within the specified period.

Because the Canadian licensed importer is the holder that applies and bears the notification and information obligations, foreign manufacturers should not assume that the importer has full visibility of events outside Canada. Contractual arrangements, quality agreements and regulatory communication protocols should require timely flow of authorization-status information from the foreign manufacturer and its regulatory representatives to the Canadian holder. The same applies to label and bilingual information changes, manufacturing site changes and component or accessory changes that may affect the listing.

Business Impact

• Market access planning: Exceptional importation can support temporary access during a documented shortage, but it does not replace a Canadian medical device licence. Companies should keep registration and exceptional importation workstreams separate and avoid treating listing as a permanent market-access solution.
• Eligibility evidence: The four conditions under section 62.28 require a clear rationale. Teams should prepare evidence on the shortage or risk of shortage, the potential harm, the substitutability of the device and the foreign authorization basis. Same-department use or general supply delay is unlikely to be sufficient.
• Pre-import readiness: The three-business-day notification, quantity limits, cut-off dates and bilingual information requirements demand accurate product, labelling, manufacturing-site, port-of-entry and shipment data. Regulatory affairs teams should build a checklist and verify the public list entries before shipment.
• Post-market surveillance and escalation: The 72-hour clock and the continuing information obligations require an SOP for monitoring foreign authorization status, receiving alerts from affiliates and distributors, and escalating to the Canadian holder. Records of when the company received or became aware of a change are important.
• Supply-chain roles: For manufacturers relying on a Canadian licensed importer, the agreement should allocate responsibility for Health Canada notifications, bilingual information, record retention and communication with the listed regulatory authority. Distributors and CROs supporting the holder should understand the 72-hour trigger and the specified format.
• Removal risk: Removal from the list does not end all obligations immediately. Section 62.323 keeps the device treated as designated for the remaining information-obligation period, so companies should plan for continued bilingual information and safe-use support.

Overall, the update rewards companies that maintain current foreign authorization data, clear contractual interfaces with the Canadian holder and robust pre-import and post-import regulatory controls. It raises the cost of fragmented communication: a delay in passing an authorization change to the Canadian holder can compress the 72-hour reporting window and create compliance risk.