Health Canada Special Access Medical Devices Form

Health care professionals use this 9-page application to ask Health Canada's Medical Devices Special Access Program for a device not licensed in Canada, a Class III or IV custom-made device, or an emergency batch. It applies when emergency use is needed or conventional therapies have failed, are unavailable or are unsuitable. Health Canada only authorizes the import and sale; purchase and import costs aren't covered.

Who completes it

The treating health care professional completes every section, from application type and device identifiers to the medical rationale, and signs the Section H attestation. Each professional submits their own application, with only one professional and one manufacturer per form.

Submitting and payment

How to submit it
Send the completed form and any supporting documents through Health Canada's secure submission tool for the program, or by fax. Life-threatening and emergency requests are prioritized, and other requests aim for a reply within 3 working days.

Good to know

  • Blank mandatory fields, unreadable handwriting, or a typed or font signature lead to automatic rejection. Wet or digital signatures are accepted, and completing the form electronically is strongly recommended.
  • List up to 5 device identifiers matching the manufacturer's labelling; for more, attach Health Canada's spreadsheet template. Custom-made devices need written directions or design documents.
  • Section F asks for the diagnosis, why this device was chosen, which licensed devices were considered with their licence numbers, the risks and benefits, and known safety and effectiveness data.
  • Serious incidents with the device must be reported to Health Canada and the manufacturer or importer within 72 hours, and unused devices should go back to the manufacturer or importer.

Get the official form

Download the current version from the source each time; forms change without notice.

Application Form for Special Access Medical Devices

Formulaire de demande d'accès spécial aux instruments médicaux

Fill it with Vero

Upload the fillable PDF once and Vero Documents fills it from the visit note and the chart, ready for you to review and sign. Download, print, or email the finished form, with the patient’s consent.

How this list is checked

A form is listed only after its name and number were confirmed on the issuing agency’s or insurer’s own website, or in the form itself. Each entry links to that source. The list was last checked in October 2026. Forms change without notice, so download the current version from the official page before you fill it in.

Vero is not affiliated with, or endorsed by, the agencies and insurers listed here. Read our editorial policy.

Frequently asked questions

Who pays for a device authorized through the Special Access Program?

Not Health Canada. Its role is limited to authorizing the import and sale of the device to the health care professional, and purchase and importation costs aren't covered. Health Canada directs patients to their provincial or territorial health authority or private insurer. Authorization also doesn't oblige the manufacturer to sell the device.

Why might Health Canada refuse a Special Access device request?

Requests can be refused when the device or a similar one is already licensed in Canada, the use is investigational, the device is wanted because it costs less, the need isn't unique, risks outweigh benefits, conventional therapy would work, or a batch isn't justified. Incomplete or unreadable applications are rejected automatically.

Can I request devices ahead of an emergency?

Yes, as a batch request when future emergencies are expected and shipping delays would affect patients. Tick the anticipatory supply option in Section A and complete Section G with the emergency condition and the number of devices needed for one month. For a procedure within 3 days, mark it as an emergency.