Medical Devices - your responsibility

The College of Alberta Denturists exists so that Albertans may be assured of receiving safe, ethical and competent denturist services.  All health services are subject to innovations in the technology and products that you used by the profession.  In this, denturism is no exception and many new technologies and products are available on the marketplace that have been manufactured both within and outside of Canadian borders.

Although the College does not have intent to stifle advancements of the practice of denturists, it does have the responsibilities of protection of the public and denturists’ compliance with regulations and laws that are applicable to their practice.  As such, the College would like to provide members with information related to the use, sale and licensure of medical devices in Canada.

Medical devices include a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevision of a disease or abnormal physical condition[1]. Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada.[2] In the interest of the health of all Canadians, Canada has one of the most rigorous regulatory systems in the world with some of the most stringent requirements.  The Government of Canada is further strengthening the systems already in place to further ensure the safety, effectiveness and quality of the medical devices used by Canadians.

I believe that it goes without saying that all medical devices sold and/or used in Canada must be approved by Health Canada. Please know that some products may be approved by the Food and Drug Administration (FDA) in the United States but are not yet approved in Canada.  There are two types of approvals that may be issued by Health Canada.  Approval is issued in the form of a license.

• Medical device license – for the medical device itself
• Medical device establishment license – for the company (establishment) that manufactures a medical device

Medical devices have been classified by Health Canada into four categories based on the risk associated with their use.  They range from Class I which includes items such as cotton balls, tongue depressors and probes to Class IV which includes defibrillators.  Denturists will come in contact with all classes of devices in their practice but know that Class II, III and IV devices require Health Canada approval prior to their sale and use.  Those companies that manufacture Class I devices must have an establishment license.

Databases exist that list all currently and formerly approved devices and may be found here. Additionally, Health Canada has published a keyword index to assist in the class identification of medical devices. MedEffect Canada may also be a resource for recalls, advisories and safety alerts for medical devices.

It is the denturist’s responsibility to ensure that all devices that they are using in the manufacture of products and the provision of services have appropriate Health Canada licensure. Failure to do so is in contravention of the Medical Devices Regulations could be considered unprofessional conduct and subject to conduct proceedings.

[1] Government of Canada. (1985). Food and Drugs Act. Ottawa: Author. Available at: https://laws-lois.justice.gc.ca/eng/acts/f-27/.

[2] Government of Canada. (2019). Medical Devices. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html.