Ensure your Medical Devices & Products are Canadian Approved

Many of the materials, instruments and equipment used by dentists are regulated by Health Canada, which monitors and evaluates their safety, effectiveness and quality.   Under the regulations, medical and dental materials and devices are included in one of four classes of risk.  For further information, please click here: Information-Sheet-Medical-Devices-and-Health-Cana.aspx (denturists-cdo.com)

Dentists must use materials, instruments and equipment that have been authorized for sale by Health Canada.  Additionally, dentists who import dental prostheses from outside Canada must ensure that the offshore laboratory or manufacturer has a Class III licence that covers fabrication of crowns, bridges, dentures etc.  Please refer to the following document from the College of Denturists for additional information: Information-Sheet-Medical-Devices-and-Health-Cana.aspx (denturists-cdo.com).  The information in this document also applies to dentists.

Review these Health Canada websites to determine whether the medical device or product being used has been approved for sale in Canada:

About medical devices - Canada.ca

Drug and health product review and approval - Canada.ca

Dentists should not use a product or medical device not included in these websites, unless they have received confirmation from Health Canada of approval for sale in Canada.  

The use of non-approved Health Canada products and medical devices may pose risks to patients.  Dentists may also be investigated for professional misconduct for not maintaining the standards of practice of the profession.