Purchase of Licensed Medical Devices for Use in Healthcare Facilities

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Contact: Medical Devices Bureau Enquiries

Therapeutic Products Directorate
Medical Devices Bureau
150 Tunney's Pasture Driveway
Room 1605 Main Building
Tunney's Pasture
Address Locator: 0301H1
Ottawa, Ontario
K1A 0K9

December 14, 2009

File number: 09-137496-189

To: Hospital Administrators, Hospital Risk Managers, Hospital Infection Control Practitioners, Hospital Purchasing Departments, Hospital Biomedical Engineering Departments, Provincial and Territorial Ministries of Health

Subject: Purchase of Licensed Medical Devices for Use in Healthcare Facilities

This letter is being sent to remind health care facilities and practitioners that medical devices imported or purchased for use in health care facilities must comply with the Canadian Medical Devices Regulations (Regulations). Class II, III or IV medical devices require authorization by Health Canada (by way of a device licence) before they can be legally imported and sold in Canada. In contrast to licensed devices, unlicensed devices have not undergone any assessment by Health Canada as to their safety, quality or effectiveness. Facilities who import and purchase unlicensed devices may place the health and safety of their staff and patients at risk.

Health Canada asks that all health care facility staff responsible for purchasing medical devices have relevant knowledge of the requirements of the  Regulations. Informing staff of regulatory requirements will help to assure that your health care facility complies with all applicable requirements.

In brief, Section 26 of the Regulations prohibits the importation and sale, including offering for sale by way of advertisement, of a Class II, III or IV medical device, unless the manufacturer of the device holds a medical device licence. Health Canada advises that medical devices that are not licensed for sale in Canada should not be purchased by health care facilities.

An exception to the above exists in the case of Class III or IV custom-made devices, medical devices for special access, and medical devices for the purpose of conducting investigational testing. Importation or sale under these circumstances is possible if the relevant sections of the Regulations are met and Health Canada has granted authorization.

Advertising Class II, III or IV medical devices for sale prior to obtaining a medical device licence is prohibited. A manufacturer's response to a Request for Proposal (RFP) is also considered to be an "offer for sale;" therefore, if a manufacturer responds to a RFP with a submission of an unlicensed medical device, it would be in contravention of the Regulations. Before entering into any contractual agreement with a manufacturer, we strongly recommend that health care facilities verify that the medical device is licensed by Health Canada.

Information on licensed devices can be obtained from the Medical Devices Active Licence Listing (MDALL) available on the Health Canada Web site. This Web site also includes a licence history archive containing devices that were previously licensed for sale and are no longer active.

Further information on the importation, sale, advertising, and licensing requirements of the Medical Devices Regulations maybe obtained on the Health Canada Web site.

If a healthcare facility has a question or concern regarding the licensing status of a medical device they should contact the Medical Devices Bureau at 613-957-4786.

Yours sincerely,

Original signed by
Roland Rotter,
Director,
Medical Devices Bureau