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Canadians rely on a diverse range of medical devices to diagnose, prevent, or treat a disease, disability, or physical condition. Products such as dialysis equipment, pacemakers, and baby incubators have improved or saved the lives of many. Other medical devices such as medical gloves, syringes, X-ray equipment, and surgical lasers are indispensable to today's health care practitioners.
Health Canada, through its Health Products and Food Branch (HPFB), is responsible for medical devices in Canada. HPFB monitors and evaluates the safety, efficacy and quality of diagnostic and therapeutic medical devices, so that consumers and health care professionals can use them with confidence.
Recent advances in technology and health research are contributing to the rapid development of new medical devices. HPFB works to balance the risks associated with any new health science innovation with the benefits that medical devices can provide to Canadians.
All medical devices in Canada are subject to the Food and Drugs Act and its regulations.
Medical devices are categorized into four classes based on the level of risk associated with their use. Class I devices present the lowest potential risk (e.g. thermometers) and Class IV devices present the greatest potential risk (e.g. pacemakers). Class II, III, and IV devices receive increasingly rigorous reviews, and must be licensed before being sold in Canada. Class I devices do not require licenses, but manufacturers must ensure that devices are designed and manufactured to be safe, as required by the Medical Devices Regulations.
The Special Access Programme (SAP) allows health care professionals to gain access to medical devices that have not yet been approved for sale in Canada. Special access can be requested for emergency use or if conventional therapies have failed, are unavailable or are unsuitable to treat a patient. The authorization permits the importation or sale of unlicensed medical devices and Class III and IV custom-made medical devices.
Class III and IV medical devices, whether they are manufactured in Canada or abroad, are carefully reviewed before being authorized for sale in Canada. The Medical Devices Bureau, part of the Therapeutic Products Directorate in HPFB, does this work.
The Medical Devices Bureau also works closely with the HPFB Inspectorate to monitor approved medical devices for compliance with Canadian medical devices regulations and Health Canada guidelines, after they become available on the Canadian market. If a medical device's safety or its effectiveness comes into question, the manufacturer may be required to recall or refit the device. If necessary, the Bureau will suspend a product's license.
Health Canada's priority is the continued health and safety of Canadians. Through its ongoing efforts, Canadians can have full confidence in the medical devices they have come to depend on.
Health Products and Food Branch
250 Lanark Avenue
Graham Spry Building
Address Locator: 2005A
Ottawa ON K1A 0K9
Web site: www.healthcanada.gc.ca/hpfb
Therapeutic Products Directorate
Medical Devices Bureau
2934 Baseline Road, Tower B
Ottawa ON K1A 0K9
Web site: www.healthcanada.gc.ca/medicaldevices