Medical Device Legalities
The legalities of buying, selling, and using medical devices in Canada can be ambiguous. While this page is certainly not legal advice, we put this information here to hopefully clear up some common questions and misunderstandings.
Medical device and medical kit sales in Canada are regulated by the Food and Drug Act and the Medical Device Regulations. These are typically enforced by Health Canada.
Medical devices are categorized in Classes between I and IV, with Class I being least invasive, and Class IV being most invasive. These Classes do not align with the U.S. FDA medical device classes. Import and Distribution of Class II or higher Medical Devices in Canada requires the importer/distributor to hold a current Medical Device Establishment License (MDEL) with Health Canada that notes the correct and applicable Class(es), activities, and manufacturers.
“Medical Kits” are referred to as Medical Device Groups in the Regulations. These include products like Individual First Aid Kits that are sold as a kit and contain multiple medical devices, usually in a case or pouch. Any company that assembles two or more medical devices together, labels and sells it as a single product, is considered a manufacturer. If that Medical Device Group contains one or more Class II or higher medical devices, then the “Kit” is then considered a Class II Medical Device. As an example, a pair of Nitrile medical exam gloves are considered Class II. As such, the manufacturer must hold in good standing a Medical Device License for that product with Health Canada. To apply for a Health Canada Medical Device License, a manufacturer must be ISO 13485-MDSAP Certified.
What that means, is that the process to lawfully create and sell a “medical kit” in Canada that contains a Class II device is complex and challenging to accomplish. It is recommended that you, as a customer, ensure that if you are purchasing a medical kit, that you do so with this knowledge and from reputable and ethical companies that conduct business lawfully.
In Canada, there is no requirement for a prescription to purchase Medical Devices that are not controlled drugs. CTOMS applies no restrictions to the sale of advanced medical devices. The legalities of using these devices are governed by federal and provincial laws regarding practicing medicine and paramedicine. Please refer to your applicable local laws for more details and see CTOMS Sales Policy for more details on usage and CTOMS’ liability waiver.