The term “medical devices”, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. In Canada medical devices are licensed in accordance with the Medical Devices Regulation (MDR). The MDR sets out the requirements governing the sale, importation, and advertisement of medical devices. However, it does not regulate the use of medical devices. 

Consequently, naturopaths (NDs) are not specifically mandated by the MDR to use medical devices that have been authorized by Health Canada. Nevertheless, while it is ultimately the manufacturer’s responsibility to ensure that medical devices have valid licences, Health Canada advises that medical devices that are not licensed for sale in Canada should not be purchased by healthcare practitioners or healthcare facilities.

Naturopaths are encouraged to make reasonable efforts to confirm the licensing status of a medical device before and after they buy and use one, by searching Health Canada’s Medical Devices Active Licence Listing (MDALL). MDALL contains product-specific information on all medical devices that are currently licensed for sale in Canada or have been licensed in the past.

The College reminds its Members that it is the responsibility of each ND to be well-informed about medical devices used in their practice and to base their use on sound scientific evidence. 

It is also important to consider this question in light of the College’s Code of Ethics and Standards of Practice. In contrast to licensed devices, unlicensed devices have not undergone any assessment by Health Canada as to their safety, quality, or effectiveness. NDs who choose to purchase unlicensed devices may therefore place the health and safety of their patients at risk.

If an unlicensed device is being used, the ND should inform the patient that the requisite Health Canada approvals are not in place, provide the patient with sufficient information to make informed decisions about healthcare they receive, and obtain and document the patient’s consent for the treatment. NDs must ensure that the patient’s interests are paramount and that their professional obligations are being met.