Medical Devices Regulations

21 (1) No person shall import or sell a medical device unless the device has a label that sets out the following information:

• (a) the name of the device;

• (b) the name and address of the manufacturer;

• (c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

• (d) in the case of a Class III or IV device, the control number;

• (e) if the contents are not readily apparent, an indication of what the package contains, expressed in terms appropriate to the device, such as the size, net weight, length, volume or number of units;

• (f) the word “Sterile”, if the manufacturer intends the device to be sold in a sterile condition;

• (g) the expiry date of the device, if the device has one, to be determined by the manufacturer on the basis of the component that has the shortest projected useful life;

• (h) unless self-evident to the intended user, the medical conditions, purposes and uses for which the device is manufactured, sold or represented, including the performance specifications of the device if those specifications are necessary for proper use;

• (i) the directions for use, unless directions are not required for the device to be used safely and effectively; and

• (j) any special storage conditions applicable to the device.

(2) The information required pursuant to subsection (1) shall be expressed in a legible, permanent and prominent manner, in terms that are easily understood by the intended user.