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Medical Devices Regulations

Version of section 44 from 2018-12-29 to 2020-06-17:

  •  (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.

  • SOR/2018-225, s. 2
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