Government of Canada / Gouvernement du Canada
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Medical Devices Regulations

Version of section 44 from 2006-03-22 to 2018-12-28:

  •  (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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