Medical Devices Regulations

62.32 (1) The holder of an establishment licence shall not sell a designated medical device that they imported under section 62.29 unless they ensure that the information referred to in clause 62.29(a)(ii)(E) is available in English and French and in a manner that permits the safe use of the device.

(2) Subject to subsection (3), the holder shall ensure that the information is available in accordance with subsection (1) until at least the end of the day on the latest expiry date of the designated medical devices that they imported.

(3) If the designated medical device does not have an expiry date, the holder shall ensure that the information is available in accordance with subsection (1) until at least the expiration of the period that corresponds to the projected useful life of whichever of the devices that they imported has the latest projected useful life.