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.
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