Purchase of Licensed Medical Devices for Use in Health Care
Programme des produits thérapeutiques
Immeuble principale Statistique Canada
Indice de l'adresse: 0301H1
January 15, 2001 / le 15 janvier 2001
To: Hospital Administrators, Biomedical Engineers and Purchasing Agents
Purchase of licensed medical devices for use in health care
This letter is being sent to remind health care facilities that many types of medical devices require a Canadian Medical Device Licence before they may legally be sold in Canada. Health care facilities have an important part to play in ensuring that the devices they use to deliver patient care are safe and effective, and comply with Canadian regulations, by verifying the licence status of the product prior to purchase.
In July, 1998, new Medical Devices Regulations were implemented in Canada to improve the safety of medical devices sold in Canada and to bring Canada's regulations in line with those of our major trading partners. An important feature of the new regulations was the establishment of device classes and licensing requirements
Classes of Medical Devices
Under the Regulations, all medical devices are classified into four classes. There are two separate classification systems, one for in vitro diagnostics and one for all other devices. Class I is the lowest risk class, and Class IV is the highest. Class I non-in-vitro devices include, among other types, those that make only non-invasive contact with the patient and do not transmit energy to the patient. Classes II, III and IV include devices of increasingly higher risk as determined by such factors as their degree of invasiveness, the hazards of energy transmission, and the potential consequences to the patient in case of device malfunction or failure.
All Class II, III, and IV medical devices sold in Canada must have a valid Medical Device Licence issued by the Therapeutic Products Directorate of Health Canada before they may be sold. Class I devices do not require a licence.
Responsibilities of Manufacturers and Distributors
A manufacturer must obtain a licence before importing, advertising or selling any Class II, III, or IV device. A distributor of medical devices cannot legally sell an unlicensed device. Additionally, distributors of medical devices are required to obtain an Establishment Licence from Health Canada to ensure that proper distribution records and complaint handling procedures are in place. Note that medical devices sold by foreign manufacturers directly to health care facilities are also required to have a valid Canadian Medical Device Licence
Health Care Facilities
It is the manufacturer's responsibility to ensure that medical devices have valid Canadian Medical Device Licences. However, Health Canada advises that health care facilities verify that all Class II, III, and IV devices have valid licences before purchasing and using them. Manufacturers or distributors can provide you with copies of the licence issued to them by Health Canada.
The Register of Licensed Medical Devices
The Therapeutic Products Programme posts a list of all licensed medical devices on its Internet web site
Health care facilities contemplating the purchase of a Class II, III or IV device can use this listing to verify that the manufacturer has a valid licence.
Medical device problem reporting is an essential element in the continued efforts of Health Canada to protect the health and safety of Canadians. While only manufacturers are required by the Regulations to report medical device problems, Health Canada encourages anyone purchasing, using or maintaining these products to report problems.
Call 1-800-267-9675 to report problems encountered with medical devices used in your health care facility.
The web site of the Drugs and Health Products
The complete text of the Medical Devices Regulations
Further information on licensed devices or the licensing requirements of the Medical Devices Regulations may be obtained from Don Boyer, Manager, Device Licensing Services Division, Medical Devices Bureau.
Tel: (613) 957-7090; Fax: 613-957-7318. E-mail: Don_Boyer@hc-sc.gc.ca
Acting Director / Directrice par intérimaire
Medical Devices Bureau / Bureau des materiels médicaux
Therapeutic Products Programme / Programme des produits thérapeutiques
Phone / Tél: 613-957-4786
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