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
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.
Related Reading
More Information
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.
Ontario Contact(s):
Mr.
Kirchner
Richard
Medical Devices Unit
Health Protection Branch
Health Canada
2301 Midland Avenue
Toronto, Ontario
M1P 4R7
Telephone: (416) 973-1596
Fax: (416) 954-4581
Toll-free (information): 1-866-662-0666
E-mail: Tor_Prodsafe@hc-sc.gc.ca
National Contact(s):
Director, Medical Devices
Therapeutic Products Directorate
Health Protection Branch
Health Canada
A.L. 0301H1, Room 1605, Main Statistics Canada Building, Tunney's Pasture
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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