Medical Devices Regulations

44 (1) No person shall import or sell a medical device unless the person holds an establishment licence.

(2) Subsection (1) does not apply to the importation or sale of a medical device by

• (a) a retailer;

• (b) a health care facility;

• (c) in the case of a Class II, III or IV medical device, the manufacturer of the medical device; or

• (d) in the case of a Class I device, the manufacturer of the medical device, if the manufacturer imports or distributes solely through a person who holds an establishment licence.

(3) Any person who imports a medical device shall ensure that the person from whom they import it holds an establishment licence.

(4) Subsection (3) does not apply where a person imports

• (a) in the case of a Class I medical device, from the manufacturer of that medical device if the person importing it holds an establishment licence; and

• (b) in the case of a Class II, III or IV medical device, from the manufacturer of that medical device.