Medical Devices Regulations

62.26 (1) The Minister may request that the manufacturer of a medical device — or any importer or distributor of a medical device — provide the Minister with information that is in their control if the Minister has reasonable grounds to believe that

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

• (b) a shortage of the device presents or may present a risk of injury to human health;

• (c) the information is necessary to establish or assess

  • (i) the existence of a shortage or risk of shortage of the device,

  • (ii) the reason for a shortage or risk of shortage of the device,

  • (iii) the effects or potential effects on human health of a shortage of the device, or

  • (iv) measures that could be taken to prevent or alleviate a shortage of the device; and

• (d) the manufacturer, importer or distributor will not provide the information without a legal obligation to do so.

(2) The manufacturer, importer or distributor shall provide the requested information electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister.