Medical Devices Regulations
(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
- SOR/2018-225, s. 2
- Date modified: