Request access to a medical device through the Special Access Program

Who can apply

As a health care professional, you may request a custom or unlicensed medical device through Health Canada’s Special Access Program (SAP).

The medical device must address an exceptional need for patients under your care where:

emergency use is required or
conventional therapies have failed, aren’t available or aren’t suitable

Also, you must be entitled under the laws of your province to provide health services in that province.

Learn more:

What medical devices may be considered

The types of devices that may be considered through a SAP application include a:

class III or IV custom-made device for a specific patient
medical device that’s not authorized for sale in Canada for a specific patient or
batch of medical devices that aren’t authorized for sale in Canada

For a patient-specific custom-made device

A custom-made device is made according to your specific directions, based on the needs of your patient requiring the device.

Your application must include one or more sketches or written directions that explain the design of the device.

Devices not considered custom-made for the purposes of special access include:

glasses
orthotics
devices that are available from a dispenser
patient-matched medical devices defined by the International Medical Device Regulators Forum Definitions for Personalized Medical Devices

For a batch request for multiples of the same device

You may request multiple units of the same device for exceptional need if:

you anticipate future emergencies and
shipping delays will cause negative outcomes for your patients

You should estimate the number of devices needed for emergency use over a 1-month period.

How to apply

To request access to a medical device under SAP:

complete and sign the Application Form for Special Access Medical Devices
use and attach Health Canada’s spreadsheet template to list more than 5 identifiers
use the Medical Devices Special Access Program secure submission tool to submit the form or fax it to 613-957-1596

Personal information given in the application is protected. Only a patient's initials or patient identifiers are used to distinguish between applications and to avoid duplication.

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How we process requests

Our Medical Devices Directorate first checks that the application qualifies for SAP. We then use the criteria in the Medical Devices Regulations to make our decision.

Devices required for life-threatening or emergency situations have priority. For all other applications, we aim to reply within 3 working days.

We may take longer if:

we aren’t familiar with the device or
an applicant hasn't given sufficient information to support the request

Criteria for refusing an application

We will refuse a request that doesn’t meet the SAP requirements. For example, we will refuse a request if we determine the device is:

already licensed for sale in Canada
or a similar device exists
being used for investigational purposes
being requested because it costs less than a licensed alternative

We will also refuse a request if the:

patient’s need isn’t unique
risks outweigh the benefits
patient can be managed through an existing conventional therapy
manufacturer or importer has circumvented the licensing requirements
rationale supporting a batch request for multiple units of the same device is not considered justified
health care professional, device importer or manufacturer didn’t provide more information as requested

We automatically reject requests for special access if the application is:

incomplete
not clear enough to be read or
fields marked as mandatory are left blank

Device cost

We’re only responsible for authorizing the importation and sale of a device to a health care professional. Expenses related to purchase or importation fees are not part of this.

Funding for the delivery of health care is under the jurisdiction of the provinces and territories. Patients should consult with their health care professional, private insurer or provincial/territorial health authority to recoup costs associated with their medical procedures.

Decision to sell or import

Although we may authorize a medical device through SAP, manufacturers or importers are not obligated to sell or import the authorized device. We don’t have the authority to require manufacturers or importers to make a device available in Canada.

Mandatory reporting requirements

Serious adverse events caused by a medical device must be reported within 72 hours to both Health Canada and the device manufacturer or importer.

An adverse event is an incident that has led to the death or serious deterioration in the health of a patient, user or other person, or could do so were it to recur. The adverse event can be due to:

the device failing
a deterioration of its effectiveness
inadequate labelling or directions for use

Use the appropriate form to report an adverse reaction:

Mandatory Medical Device Problem Reporting Form for Industry if you’re a manufacturer, supplier or importer
Mandatory Reporting Form for Health Care Professionals if you’re a health care professional

Contact us

Our hours of service are 8:00 a.m. to 4:00 p.m. Eastern Standard Time, Monday to Friday, excluding statutory holidays. We do not monitor our inboxes outside of regular business hours.

For questions about the Special Access Program:

Medical Devices Directorate
Telephone: 613-946-8711 or 343-552-5753
Fax: 613-957-1596
Email: sap.devices.mdb@hc-sc.gc.ca
Emergency request (outside normal hours): 613-410-9186

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2026-08-21

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