Canada-Ontario Business Service CentreMedical DevicesHealth 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.SummaryThe 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 9. Protection of Personal Information: Your Responsibilities The Guide to Canada's Personal Information Protection and Electronic Documents Act (PIPEDA) helps businesses understand their obligations and comply to the Act. Since January 1, 2004, the PIPED Act covers the collection, use or disclosure of personal information in the course of all commercial activities in Canada, except in provinces which have enacted legislation that is deemed to be substantially similar to the federal law. For more information, see the document Ontario Contact(s):
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 |
| Last Modified: 2004-09-29 |