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: (613) 946-8711
Fax: (613) 957-1596
sap_devices_mdb@hc-sc.gc.ca
or visit our Website at:
www.hc-sc.gc.ca/dhp-mps/index_e.html
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