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Canada Updates Exceptional Import Medical Device Forms With New Declaration Requirements

Time：2026-09-07 13:50:24

On September 2, 2026, Health Canada officially released an announcement announcing a comprehensive update to two core submission forms (FRM‑0577 and FRM‑0578) for the exceptional importation and sale of foreign‑authorized medical devices. This regulatory revision is intended to streamline review workflows while strengthening end‑to‑end compliance oversight for exceptionally imported medical devices. It will directly impact all manufacturers and import agents conducting exceptional medical‑device import business into Canada.

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https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/updates-forms-exceptional-importation-sale.html

一、Policy Background

Canada’s exceptional importation and sale regime for medical devices provides a regulatory pathway allowing medical devices legally approved in foreign jurisdictions to be imported and sold in Canada under special circumstances, such as shortages or imminent shortage risks of domestically‑licensed medical devices.

FRM‑0577 and FRM‑0578 are the two most frequently‑used core forms under this regime. The form revisions aim to improve user submission experience, streamline review procedures, and enhance end‑to‑end traceability and compliance management for imported products.

二、General Changes Applicable to Both Forms

The following common revisions apply to both FRM‑0577 and FRM‑0578:

Full migration to online submission：The previous PDF‑based forms have been replaced by web‑based online forms; all submissions must be completed digitally.

Multi‑format attachment support:：Where information cannot be fully entered into form text fields, supplementary attachments may be uploaded. Supported formats include JPG, PNG, DOC/DOCX, XLSX, GIF and PDF.

New compliance declaration requirement：Submitting entities must provide an official declaration confirming they have established implemented procedures covering five compliance areas: maintenance of distribution records, complaint‑handling mechanisms, adverse‑event reporting workflows, notification protocols for serious human‑health risks, and product recall management procedures.

三、Key New Requirements for FRM‑0577 (List Addition Application)

FRM‑0577, full title Proposal for adding a foreign‑authorized device to the List of medical devices for exceptional importation and sale, is used to apply for adding foreign‑authorized medical devices to the Exceptional Import and Sale List or requesting amendments to existing list entries.

The updated form significantly expands required submission information and documentation. New data fields include：

Name of the foreign regulatory authority that granted marketing authorization for the device
Justification and supporting evidence for the exceptional‑import application
Documentation proving shortages or imminent shortage risks of domestically‑licensed Canadian medical devices
Justification demonstrating that the proposed imported device is a viable alternative for the Canadian shortage situation
Proposed latest import date for each device identifier
Total proposed exceptional‑import quantity for each device identifier

Mandatory supporting documentation package: intended‑use statement for the proposed imported device, safe‑use information for the device, valid foreign marketing authorization, and valid Quality Management System (QMS) certification held by the manufacturer.

Note: Health Canada reserves the right to request additional information or supporting materials from importers on a case‑by‑case basis.

四、Critical Revisions to FRM‑0578 (Arrival Notification Form)

FRM‑0578, full title Medical device exceptional importation and sale notification form, is for submitting pre‑arrival notifications to Health Canada before exceptionally‑imported medical devices arrive at Canadian ports of entry.

Two major business‑impacting changes have been introduced:

Shortened submission deadline：The prior requirement of submission 5 working days pre‑arrival has been reduced to 3 working days prior to goods arrival. Businesses must accelerate coordination between logistics and compliance teams accordingly.

New product‑traceability fields：Mandatory reporting of production lot numbers and expiry dates for exceptionally‑imported medical devices to strengthen full‑supply‑chain traceability.

五、Compliance Recommendations for Enterprises

In response to these form updates, relevant companies are advised to implement the following adjustments promptly to avoid disruptions to import operations:

Adapt to the new online submission portal：Discontinue use of legacy PDF forms. Familiarize yourself with Health Canada’s web‑form navigation and logic; conduct trial test submissions to identify common pitfalls.

Optimize internal cross‑functional workflows：With the arrival‑notification lead time cut from 5 to 3 working days, accelerate information hand‑offs among internal compliance, logistics and customs teams, and build in time buffers to prevent customs hold‑ups caused by late submissions.

Pre‑compile submission document packages：Proactively organize standardized product‑level documentation addressing new FRM‑0577 requirements including foreign regulatory information, shortage evidence, alternative‑product justification and QMS certification, to minimize post‑submission correction delays.

Review internal compliance systems：Audit existing internal processes for distribution records, complaint handling, event reporting and product recalls against the five new compliance‑declaration criteria. Ensure declared statements align with actual operations to mitigate risks from false declarations.

Strengthen supply‑chain information alignment：Establish information‑sharing protocols with upstream suppliers and logistics providers to rapidly obtain accurate lot‑number and expiry‑date data required for the updated form fields.

六、Conclusion

These revisions to Canada’s exceptional‑import medical‑device forms reflect a regulatory approach balancing improved administrative efficiency and stricter compliance oversight. For further inquiries, please consult Wiselink.

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