The Medical Devices Special Access Programme
Contact: Special Access Programme Devices
Questions and Answers
- What is the purpose of the Medical Devices Special Access Programme?
- Who can apply for special access to medical devices?
- Which medical devices are available through the SAP?
- Should I submit an application to the Special Access Programme for my COVID-19 medical device?
- What is a custom-made device?
- Who determines whether or not a medical device is released under the SAP?
- Is personal information and patient anonymity protected?
- How quickly can I expect a decision be made on an application?
- Who pays for medical devices released through the SAP?
- Are Special Access applications ever refused?
- What are the reporting requirements for a health care professional using a medical device authorized through the SAP?
- What are the Medical Devices SAP's hours of service?
1. What is the purpose of the Medical Devices Special Access Programme?
The Medical Devices Special Access Programme (SAP) is responsible for administering Part 2 of the Medical Devices Regulations, the Special Access Provisions, under the Food and Drugs Act. This part of the Regulations permits health care professionals to access custom-made and unlicensed medical devices for emergency use or when conventional therapies have failed, are unavailable or are unsuitable to provide a diagnosis, treatment or prevention for patients under their care.
2. 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 Medical Devices SAP.
3. Which medical devices are available through the SAP?
A health care professional licensed to practice in Canada can apply for an authorization to import and/or sell a Class II, III, or IV medical device or a Class III or IV custom-made device, provided that the device is not already licensed for sale in Canada, and that the application satisfies the criteria set out under the Regulations.
4. Should I submit an application to SAP for my COVID-19 medical device?
Healthcare professionals should contact SAP if they are seeking access to COVID-19 devices not authorized for sale in Canada, where that access is for emergency use or when conventional therapies have failed, are unavailable or are unsuitable to treat a patient.
Manufacturers who wish to sell or import their COVID-19 devices in Canada should refer to How to get authorization. Manufacturers and importers cannot receive authorization for sale or import of their devices through SAP.
5. 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 produced for a particular patient or procedure. Custom-made devices exclude those devices which are generally available from a dispenser such as orthotics or glasses.
6. Who determines whether or not a medical device is released under the SAP?
The Medical Devices Bureau (MDB) is responsible for assessing the application and makes the decision if a device can be made available for special access based on the criteria set out under the Regulations.
7. Is personal information and patient anonymity protected?
Yes. Personal information provided in the application is protected. Only the patients = initials or identifiers are used to distinguish between applications and to avoid duplication. Occasionally, the patient's age may be required in determining the benefits and the risks of using a particular device. For example, children who are still growing would not be suited for certain types of hip implants.
8. How quickly can I expect a decision be made on an application?
Devices required for life threatening or emergency conditions are processed immediately. The performance standard for all other applications is to provide a response within three working days. Failure to provide complete information will result in delays.
9. Who pays for medical devices released through the SAP?
The Medical Devices SAP is responsible only for permitting the importation and sale of a device to a health care professional. The funding for the delivery of health care is under provincial jurisdiction. Patients should consult their health services providers, their provincial health care system or a private insurer for costs associated with their medical procedures.
10. Are Special Access applications ever refused?
Yes. It is the health care professional's responsibility to submit a complete application which explains why a particular unlicensed device is required for the diagnosis, treatment or prevention for their patient. The information required must identify the medical condition of the patient and why conventional therapies or licensed devices have failed or are unsuitable. A discussion of the risks and benefits associated with the use of the unlicensed device must be provided. If a determination is made that the potential risks associated with the use of the device outweigh the potential benefits or if a similar medical device is already licensed for sale in Canada, the application will be refused.
11. What are the reporting requirements for a health care professional using a medical device authorized through the SAP?
In the event of a serious adverse event with a medical device, the health care professional must report to MDB and to the manufacturer or importer within 72 hours after the occurrence. This includes any incidents related to a failure of the device or a deterioration of its effectiveness, or any inadequacy in its labelling or directions for use and that have led to the death or serious deterioration in the state of health of a patient, user or other person, or could do so were it to recur. A copy of the Medical Devices Problem Report Form can be obtained from the Health Products and Food Branch Inspectorate Web site at: http://hc-sc.gc.ca/dhp-mps/compli-conform/index-eng.php
12. What are the Medical Devices SAP's hours of service?
The hours of service are 8:00 a.m. to 4:30 p.m., EST, Monday to Friday excluding statutory holidays.
For further information, contact:
Special Access Programme
Device Evaluation Division
Medical Devices Bureau
Therapeutic Products Directorate
Main Statistics Canada Building
150 Tunney's Pasture Driveway
Address Locator 0301H1
Tel: (613) 946-8711
Fax: (613) 957-1596
Web site: https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/medical-devices.html
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