Health Canada's special access programs: Request access to a medical device

Who can apply

Through the special access program (SAP) for medical devices, health care professionals can access custom-made and unlicensed medical devices for patients under their care. To be eligible, they must be entitled under the laws of their province to provide health services in that province.

These medical devices are to be used:

for emergency use
when conventional therapies have failed, are unavailable or are unsuitable to treat a patient

Eligible health care professionals can apply to have a manufacturer authorized to import or sell:

class I, II, III or IV medical devices
class III or IV custom-made devices

Requests can be made for a specific patient or, in some cases, for batches of Class I to IV medical devices.

How to apply

You can apply for a medical device that is not authorized for sale in Canada for your patient. The types of devices that you can apply for include:

a class III or IV custom-made device for a specific patient
any device not authorized for sale in Canada for a specific patient
a batch of medical devices that are not 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 1 or several custom 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
those that are available from a dispenser

For a batch request for multiples of the same device

You can request multiples of the same device for anticipated emergency cases if:

a licensed medical device is unavailable
shipping delays will cause negative outcomes for patients

You will need to estimate the number of devices you will require for emergency use for 1 month. This 1-month restriction is to ensure there are enough quantities to meet short-term emergency needs. We will use our discretion when enforcing this restriction.

To request access to a medical device, complete and sign the Application Form for Custom-Made Devices and Medical Devices for Special Access.

Cost

We are 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 our responsibility.

Funding for the delivery of health care is under provincial jurisdiction. Thus, for costs associated with their medical procedures, patients should consult with their health care professional, private insurer or provincial health authority.

Information for manufacturers and health care professionals

Although we may issue an authorization for a device through SAP, a manufacturer is not obligated to sell a device for special access purposes. We cannot compel a manufacturer to do so.

How we process requests

Our Medical Devices Directorate reviews the application. We follow the criteria set out under the regulations when making our decision.

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

We may take longer if:

an applicant hasn't given enough information on the device's safety and effectiveness or
we are unfamiliar with the device

For patient-specific requests, we weigh the benefits and risks of a device against information about the patient, such as:

sex
age
comorbidities
diagnostic status

For example, children who are still growing would not be suited for certain types of hip implants.

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.

Criteria for refusing an application

A request is refused if:

the application is incomplete
an explanation has not been provided to explain why a particular unlicensed device is required for:
- diagnosis
- treatment
- prevention
an explanation for why conventional therapies or licensed devices have failed or are unsuitable has not been provided
in the case of a patient-specific request, the applicant has not identified the patient's medical condition
the risks and benefits associated with the use of the unlicensed device have not been explained well enough
the risks outweigh the benefits
the health care professional, device importer or manufacturer failed to provide more information as requested
a similar medical device is already licensed for sale in Canada

We automatically reject requests for special access if the application is not clear enough to be read or is missing manufacturer or importer information.

Mandatory reporting requirements

If a medical device has caused a serious adverse event, health care professionals must report to Health Canada and to the device manufacturer or importer. They must do so within 72 hours after the incident has taken place.

Adverse events are incidents that have 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

Manufacturers, suppliers and industries report using the Mandatory Medical Device Problem Reporting Form for Industry.

Health care professionals report adverse reactions using the Mandatory Reporting form for Health Care Professionals.

Contact us

Hours of service are 8:00 a.m. to 4:30 p.m. Eastern Standard Time, Monday to Friday excluding statutory holidays.

For questions about the program, contact us:

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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Date modified:: 2020-10-20

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