Hamburg, 08.01.2020, Dr. Silvia Georges

Health Canada published its finalized guidance on software as a medical device (SaMD). The guidance aids medical device manufacturers and other stakeholders in understanding which products qualify as SaMD as well as in the classification of the device. SaMD includes software intended to be used for one or more medical purposes as outlined in the definition of device in the Food and Drugs Act. Thereby, it fulfills the definition without being part of a hardware medical device meaning that software, which drives a medical device, is excluded from being a SaMD. After determination that a software is a medical device, the guidance assists in the classification according to Schedule 1 of the Medical Devices Regulations. Read the full version of the guidance here.