Health Canada Updates Forms for Exceptional Importation and Sale of Medical Devices
Health Canada has published updated forms related to the exceptional importation and sale of foreign-authorized medical devices.
The update was published on 2 September 2026 and applies to two forms: FRM-0577 and FRM-0578.
Updated Forms
Health Canada identifies two updated forms.
FRM-0577, titled “Proposal for adding a foreign-authorized device to the List of medical devices for exceptional importation and sale,” is used to request exceptional importation and sale of a foreign-authorized medical device or an amendment to the relevant list.
FRM-0578, titled “Medical device exceptional importation and sale notification form,” is used to notify Health Canada of an exceptional importation shipment arriving in Canada.
Purpose of the Changes
According to Health Canada, the updated forms outline the type of information requested to support proposals for exceptional importation and sale.
The changes are intended to help streamline the review process and support the processing and tracking of imported shipments of foreign-authorized medical devices.
Changes Applying to Both Forms
Health Canada states that both FRM-0577 and FRM-0578 have been changed from PDF forms to web forms.
The updated forms now allow supporting documents to be attached in JPE/JPG/JPEG, PNG, DOC(X), XLXS, GIF or PDF formats where the content does not fit in the text boxes provided.
Health Canada has also added an attestation that documented procedures or processes are in place, where applicable, for:
maintenance of distribution records;
complaint handling;
incident reporting;
providing information about any serious risk of injury to human health;
recalls.
New FRM-0577 Fields
For FRM-0577, Health Canada has added new fields covering the foreign regulatory agency authorizing the device for sale, the rationale or evidence supporting the proposal, and information demonstrating that the device authorized for sale in Canada is in shortage or at risk of shortage.
The updated form also requests information on how the proposed foreign-authorized device is an appropriate substitute for the Canadian licensed device, the proposed last date of importation for each device identifier and the proposed total number of units to be exceptionally imported for each device identifier.
Supporting documentation may include intended use information, safe use information, valid foreign regulatory authorization for sale and valid quality management system, or QMS, certification held by the manufacturer of the proposed device.
New FRM-0578 Requirements
For FRM-0578, Health Canada has changed the notification timeframe.
Importers must now notify Health Canada three business days before the date on which an exceptionally imported foreign-authorized medical device is expected to arrive at a Canadian port of entry. Previously, the notification timeframe was five business days.
Health Canada has also added a new field for the lot number and expiry date of the exceptionally imported foreign-authorized medical device.
Impact on Medical Device Importers and Manufacturers
For medical device importers and manufacturers involved in exceptional importation pathways in Canada, the updated forms introduce practical changes to submission preparation, documentation and shipment notification workflows.
Stakeholders should pay particular attention to:
use of the new web forms;
document attachment formats;
shortage or risk-of-shortage justification;
evidence supporting substitute device suitability;
foreign regulatory authorization documentation;
QMS certification documentation;
distribution record procedures;
complaint handling and incident reporting procedures;
recall procedures;
three-business-day shipment notification timeline;
lot number and expiry date reporting.
For companies supporting the Canadian market during device shortages or risk-of-shortage situations, the key message is that Health Canada is requesting more structured information to support review, shipment tracking and oversight of exceptionally imported foreign-authorized medical devices.
