|CANADA||US HOME PAGE||CONTACT US|
MEDICAL DEVICE (MD) ASSESSMENT
Health Canada has adopted a risk-based classification system which is consistent with that of other countries.
Low risk devices such as toothbrushes, surgical instruments, and collection bags are classified as Risk Class I. Blood Pressure Monitors, Digital Thermometers, and Pregnancy Test Kits are classified as Risk Class II. Higher risk devices such as dental or breast implants, prosthetics, and drug test kits are classified as Risk Class III. Highest risk devices such as artificial hearts, heart pacemakers, skin grafts, and cardiovascular stents are classified as Risk Class IV.
It is important to note that a product may have a different risk rating in Canada than assigned in other regulatory jurisdictions. It is also important to note that some products regulated as medical devices in other countries, may in fact be drugs or natural health products in Canada, based on the definitions that are found in the Food and Drugs Act (FDA).
The first stage of assessment is to work with MEDERA to assess risk classification for the Canadian market.