Medical Devices

Act: Food and Drugs Act, R.S.C. 1985, c. F-27
Regulation: Medical Devices Regulations, SOR/98-282

To Whom Does This Apply?

In Canada, manufacturers must obtain a medical device licence for certain health products defined as a device under the Food and Drugs Act before they can be sold on the Canadian market. To determine which devices need a licence, all medical devices have been categorized based on the risks associated with their use.

Prior to selling a device in Canada, manufacturers of Class II, III and IV devices must obtain a medical device licence. Although Class I devices do not require a licence, manufacturers, distributors and importers are required to obtain an establishment licence.

Summary

The term medical device covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Some examples include pacemakers, artificial heart valves, hip implants, synthetic skin, medical laboratory diagnostic instruments, test kits for diagnosis and contraceptive devices.

Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada.

Please visit Health Canada's Medical Devices Web site or contact Health Canada by telephone for fee information, guidance documents, forms and policies needed to submit all of the different types of applications.

Note: Health Canada advises that medical devices that are not licensed for sale in Canada must not be imported or purchased by health care facilities or consumers. Please use the Medical Devices Active Licence Listing (MDALL) to determine if licences are active or archived.

DISCLAIMER
Information contained in this section is of a general nature only and is not intended to constitute advice for any specific fact situation. For particular questions, the users are invited to contact their lawyer. For additional information, see contact(s) listed below.

Quebec Contact(s):
Ms. Francine Jacques
Supervisor, Quebec Region
BTOX/Medical Devices Unit
Health Products and Food Branch Inspectorate
Health Canada
A. L. 0900C2
1001 St-Laurent Street West
Longueuil, Quebec  J4K 1C7
Telephone: 450-646-1353
Fax: 450-928-4455
Toll-free (information): 1-800-267-9675
TTY Toll-free (hearing impaired): 1-800-267-1245
E-mail: francine_jacques@hc-sc.gc.ca
Web site: http://www.hc-sc.gc.ca/index_e.html

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National Contact(s):
Mrs. Barbara Harrison
A/Manager, Medical Device Compliance Unit
Health Products and Food Branch Inspectorate
Health Canada
2nd Floor
A.L. 2003C
Graham Spry Building
Ottawa, Ontario  K1A 0K9
Telephone: 613-954-6666 and 613-946-5093
Fax: 613-954-0941
Toll-free (information): 1-866-225-0709
TTY Toll-free (hearing impaired): 1-800-267-1245
E-mail: barbara_harrison@hc-sc.gc.ca
Web site: http://www.hc-sc.gc.ca/index_e.html

Mr. Roland Rotter
Director, Medical Devices Bureau
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
Room 1605
A.L. 0301H1
Statistics Canada Main Building
Tunney's Pasture
Ottawa, Ontario 
Telephone: 613-957-4786
Fax: 613-957-7318
Toll-free (information): 1-866-225-0709
TTY Toll-free (hearing impaired): 1-800-267-1245
E-mail: roland_rotter@hc-sc.gc.ca