Health Canada has issued a notice to manufacturers, importers and distributors of medical software clarifying what medical software is regulated as a Class I or Class II medical device, and how Health Canada is bringing Class I and Class II medical device software products into compliance with the Medical Devices Regulations.
All medical devices are regulated by Health Canada to ensure their safety, effectiveness and quality before being authorized for sale in Canada. Manufacturers of medical devices must satisfy specified safety requirements and must bear a label that contains specific information as described in the Regulations. The Food and Drugs Act (the “FDA”) defines a device as any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in, among other things, the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings.
Under the Medical Devices Regulations to the FDA, medical devices are classified into one of four classes based on their risk to the patient. The four risk classes, numbered I, II, III and IV, represent varying degrees of risk; I being the lowest and IV the highest. Manufacturers of Class II, III or IV medical devices must obtain a device license before the product may be sold on the Canadian market. Class I devices do not require a license, but are still subject to the safety, effectiveness, labeling and recall requirements of the Medical Device Regulations.
The Health Canada notice specified that Patient Management Software “PMS” used only for archiving or viewing information or images will be considered a Class I device; however, a software product that simply replaces a patient’s paper file would not be considered a medical device if it was intended only to store and view patient information (for example: age, weight, notes about a patient’s appointment, patient test results, order processing etc.). PMS involved in data manipulation, analysis or editing; image generation; recording of measurements; graphing; flagging of results; or performing calculations would be considered a Class II device.
Miller Thomson has significant experience with the regulation of medical devices and applying for medical device licenses. We would be pleased to assist you in determining your obligations under the Medical Devices Regulations and with the licensing process.
Health Canada has stated all Class I Medical Device Software sold after February 1, 2011 and Class II Medical Device Software sold after September 1, 2011 are expected to be compliant with the Medical Device Regulations.