The term Medical Devices, as defined in the Canadian 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”. Most people find it hard to believe that many things they use in their daily lives are considered medical devices to the regulatory world. Some of the more common types would be pacemakers, medical laboratory instruments and artificial heart valves but medical devices can also include thermometers, toothbrushes, elastic bandages and dental floss. In the United States these products are regulated by the Food and Drugs Administration (FDA) through a medical device classification system. Within Canada, the Medical Devices Bureau of the Therapeutic Products Directorate (TPD) of Health Canada (HC) regulates these products.
In order to get a medical device into the American or Canadian markets you must establish the products “class” and from there you can see what further testing and approvals are required. The FDA and HC alike classify medical devices based on the risks associated with their use. This approach means that every medical device on the market is grouped into 3 classes (US) or 4 classes (Canada).
Class I devices are deemed as low risk and are therefore subject to the least regulatory control. In Canada, these devices do not require a medical device license; they are however monitored through Establishment Licenses. This license permits importers, distributors and manufacturers of these products who do not sell through a licensed importer to operate within the country. Basically, it allows HC to be aware of the identity of establishments that are selling or manufacturing devices.
Class II devices are higher risk than Class I and require greater regulatory controls in order to provide reasonable assurance of the device’s safety and effectiveness. These medical devices must obtain a Medical Device Licenses in order to be sold on the market.
Class III and Class IV are the highest risk devices and are subject to the highest level of regulatory control. This typically includes being approved by the FDA or the TPD before being marketed.
Within Canada, when a company decides they want to market a medical device, it must submit a Medical Device License Application. The amount of detail within this application is subject to the classification level of the device. Once it is submitted the TPD will review the application to see if it meets the requirements of the Medical Devices Regulations. If so, a License will then be issued. The length of review is longer for Class III and IV devices while Class II devices have only a 15 day target. Both the FDA and HC play a role in monitoring medical devices after they are licensed to ensure their continued safety and effectiveness. If there ends up being a safety issue or it is no longer effective, the License can be suspended or the manufacturer may need to recall the medical device.
Product manufacturers entering the Canadian and American market must pay close attention to the different regulations in regards to Medical Devices in order to successful in this growing industry along with maintaining strong customer loyalty.
Focal Point Research Inc. has been in business for over 25 years and are knowledgeable Medical Device Consultants; therefore we offer an immense knowledge and unique advantage in licensing and regulating these important products. Contact us for any of your medical device needs.