Medical Devices Regulations

62.29 Despite sections 21 and 26, the holder of an establishment licence may import a designated medical device if the following conditions are met:

• (a) the holder provides the Minister, in the form and manner specified by the Minister and not later than three business days before the day on which the device is imported, with a notification that contains the following information:

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

  • (ii) in respect of the 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 device, and

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

• (b) [Repealed, SOR/2026-96, s. 33]

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

  • (i) the device’s name,

  • (ii) the device’s class,

  • (iii) the name of the device’s manufacturer,

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

  • (v) the name of the regulatory agency referred to in paragraph 62.28(c),

  • (vi) the maximum limit for the total number of units of the device that the holder may import, if applicable, and

  • (vii) the date after which the device may no longer be imported;

• (d) the total number of units of the device that the holder imports does not exceed the maximum limit referred to in subparagraph (c)(vi), if applicable;

• (e) the device is imported on or before the date referred to in subparagraph (c)(vii); 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.