Open ProvincesExceptional need for an unlicensed or custom-made medical device: submit a special-access request
Exceptional need for an unlicensed or custom-made medical device: submit a special-access request
Only an eligible health care professional may request access. Lower cost, research or avoiding licensing do not justify the program.
Confirm the scope
Confirm the exceptional need, emergency or failed alternatives and check that no suitable licensed device is available.
Prepare the information
Identify the patient or emergency batch, manufacturer, model, class, quantity, use, benefits, risks and custom-device drawings.
Complete the process
Download the current form, add the identifier template if needed and submit through the secure tool or stated fax channel.
Keep follow-up records
Retain the authorization, coordinate the supplier and importer and report any covered serious incident within 72 hours.
Request a medical device through the Special Access Program — Health Canada
Sources and limits
Official sources are linked in the guide. Checked August 30, 2026; confirm current rules, forms and deadlines with the responsible authority.
General information based on federal and national rules; provincial rules may differ. Confirm with the official body before acting. Last reviewed : 2026-08-30.