Special Access Program (SAP)
What is the SAP?
Health Canada's Special Access Program (SAP) allows healthcare practitioners to access unlicensed medical devices for specific patients in exceptional circumstances when conventional therapies have failed, are unsuitable, or are unavailable.
The SAP is not a route to market — it is a compassionate use mechanism for individual patients.
Who can apply
Healthcare practitioners (licensed physicians, dentists, or other authorised practitioners) apply for SAP access on behalf of a specific patient. Patients cannot apply directly.
Manufacturers and importers do not apply for SAP access — the application comes from the treating practitioner.
Eligibility criteria
SAP access may be granted when:
- The device is for a serious or life-threatening condition
- Conventional therapies have failed, are unsuitable, or are unavailable
- There is sufficient evidence that the device may be effective
- The benefits outweigh the risks for the specific patient
Application process
- Healthcare practitioner contacts the device manufacturer to obtain product information and any relevant clinical evidence
- Practitioner submits a SAP request to Health Canada (via the SAP online portal or by phone for urgent requests)
- Health Canada reviews the request and issues an authorisation (or declines with reasons)
- Manufacturer supplies the device to the practitioner under the SAP authorisation
- The manufacturer must hold an MDEL or work through a Canadian agent who does
SAP authorisation conditions
SAP authorisations are issued for a specific patient and a specific condition. Conditions may include:
- Reporting of adverse events to Health Canada
- Follow-up clinical data submission
- Limits on quantity
Urgent requests
For urgent life-threatening situations, Health Canada can provide same-day authorisation by phone, followed by written confirmation.
Legislative source: Medical Devices Regulations, SOR/98-282, ss 66–71 (Special Access)