Medical Devices
Health Canada
Last Verified:
2003-07-17
Act:
Food and Drugs Act, R.S.C. 1985, c. F-27
Regulation:
Medical Devices Regulations, SOR/98-282
Related Reading
More Information
To Whom Does This Apply?
Manufacturers, distributors, and importers of medical devices.
Summary
The term "medical device" covers a wide range of products 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.
The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) of Health Canada is the national authority that monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada.
The TPD ensures, to the extent possible, the safety, effectiveness and quality of medical devices in Canada by a combination of pre-market review, post-approval surveillance and quality systems in the manufacturing process.
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.
Manitoba Contact(s):
Mr.
Bob
Scales
Medical Devices Inspector
Manitoba/Saskatchewan Region
Health Protection Branch
Health Canada
510 Lagimodière Boulevard
Winnipeg, Manitoba
R2J 3Y1
Telephone: (204) 983-5451
Fax: (204) 983-5547
Toll-free (information): 1-866-225-0709
TTY Toll-free (hearing impaired): 1-800-267-1245
National Contact(s):
Director, Medical Devices
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
A.L. 0301H1, Room 1605
Main Statistics Canada 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
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