Special Access Programme - Medical Devices

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Special Access Programme - Medical Devices

What is the purpose of the Special Access Programme?

The main objective of the Special Access Programme (SAP), administered by

the Therapeutic Products Directorate (TPD) of Health Canada, is to allow

access to medical devices or drugs that have not otherwise been approved in

Canada for emergency use or when conventional therapies have failed, are

unavailable or are unsuitable to treat a patient.

Who determines whether or not a medical device is released under the SAP?

The Medical Devices Bureau of the TPD reviews all Special Access requests

for medical devices. If it is determined, based on the information

submitted, that the potential benefits of using a particular device outweigh

the potential risks, the medical device is made available.

Who can apply for Special Access to medical devices?

Only health care professionals who are entitled under the laws of their

province to provide health services in that province may submit applications

to the SAP.

Is patient anonymity/ confidentiality safeguarded?

Yes. Only the patient's initials or identifier are used to distinguish

between requests and avoid duplication. Occasionally the patient's age is

essential information in determining the benefits versus the risks of using

a particular device. For example, children who are still growing would not

be suited for certain types of hip implants.

Who pays for devices released through the SAP?

The patient may be responsible for any costs not covered by the hospital,

the provincial health care system or a private insurer.

Which devices are available through the SAP?

All medical devices which are not generally available for sale in Canada, in

addition to certain custom-made devices, require Special Access

Authorization prior to being imported and/or sold in Canada.

What is a custom-made device?

A custom-made device is one which is made to correspond with a health care

professional's specific directions or needs. These devices are usually

specifically ordered for a particular patient or procedure. Custom-made

devices exclude those devices which are generally available from a dispenser

such as orthotics or glasses.

How quickly can a device be made available?

Special Access requests are given top priority. Applicants usually receive a

response within 3 working days.

Are Special Access requests ever denied?

Yes. It is the health care professional's responsibility to submit a

complete application which explains why a particular device is needed and

why no other will do. If the TPD determines that the potential risks

associated with using a device outweigh the potential benefits or if a

similar medical device is already available for sale in Canada, the request

will be denied.

For further information

Special Access Programme

Device Evaluation Division

Medical Devices Bureau

Therapeutic Products Directorate

Room 1605, Main Statistics Canada Building

Address Locator 0301H1, Tunney's Pasture

Ottawa, Ontario K1A 0L2

Tel:

Fax:

sap_devices_mdb@...

or visit our Website at:

www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/