Medical Devices Regulations

62.28 The Minister may add a medical device to the List of Medical Devices for Exceptional Importation and Sale only if the Minister has reasonable grounds to believe that

• (a) there is a shortage or risk of shortage of another medical device;

• (a.1) a shortage of the device referred to in paragraph (a), if it were to occur, could present a risk of injury to human health;

• (b) the device to be added to that list can be substituted for the device referred to in paragraph (a); and

• (c) the device to be added to that list is authorized to be sold by a regulatory agency within its jurisdiction or, if the sale of the device is not required to be authorized by a regulatory agency within its jurisdiction, the device complies with the applicable legal requirements within the agency’s jurisdiction.