Medical Devices Regulations (SOR/98-282)

62.29 The holder of an establishment licence may import a designated medical device if the following conditions are met:

• (a) the holder provides the Minister, electronically in a format specified by or acceptable to the Minister and not later than the fifth business day before the day on which the designated medical device is imported, with a notification that contains the following information:

  • (i) the holder’s name and contact information,

  • (ii) in respect of the designated medical device,

    • (A) its name and the name of each of its components, parts and accessories, including, if applicable, the model name,

    • (B) its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family,

    • (C) the name and contact information of the manufacturer of the device as it appears on the device label,

    • (D) the name and address of the establishment where it is manufactured, if different from the information referred to in clause (C), and

    • (E) a detailed description of the medical conditions, purposes and uses for which it is manufactured, sold or represented, as well as its performance specifications if those specifications are necessary for proper use,

  • (iii) the intended port of entry into Canada,

  • (iv) the estimated date of arrival of the shipment of the designated medical device, and

  • (v) the total number of units of the designated medical device that are intended to be imported on the date referred to in subparagraph (iv);

• (b) the designated medical device is authorized to be sold by a regulatory agency within its jurisdiction or, if the device is not required to be authorized by a regulatory agency within its jurisdiction, the device complies with the applicable legal requirements within its jurisdiction;

• (c) the following information is set out in the List of Medical Devices for Exceptional Importation and Sale in respect of the designated medical device:

  • (i) its name,

  • (ii) its class,

  • (iii) the name of its manufacturer,

  • (iv) the establishment licence number of the holder,

  • (v) the name of the regulatory agency referred to in paragraph (b), and

  • (vi) the date after which it may no longer be imported;

• (d) the total number of units of the designated medical device that the holder imports does not exceed the maximum limit specified in the list referred to in paragraph (c) in respect of the device, if applicable;

• (e) the designated medical device is imported on or before the date referred to in subparagraph (c)(vi); and

• (f) the holder has prepared a plan that specifies the measures to be taken in order for the holder to comply with section 62.32.