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Medical Devices Regulations (SOR/98-282)

Regulations are current to 2022-11-28 and last amended on 2022-09-27. Previous Versions

PART 1General (continued)

Shortages

 The following definitions apply in this section and in sections 62.22 to 62.26.

List of Medical Devices – Notification of Shortages

List of Medical Devices – Notification of Shortages means the List of Medical Devices – Notification of Shortages that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux – avis de pénuries)

specified medical device

specified medical device means a medical device that belongs to a category of medical devices that is set out in the List of Medical Devices – Notification of Shortages. (instrument médical inscrit)

 The Minister may add a category of medical devices to the List of Medical Devices – Notification of Shortages only if the Minister has reasonable grounds to believe that a shortage of a device that belongs to the category presents or may present a risk of injury to human health.

  •  (1) Subject to subsections (2), (7) and (9), if a shortage of a specified medical device exists or is likely to occur, the manufacturer of the device and, in the case of a Class I device, the importer of the device shall each provide the following information to the Minister electronically in a format specified by or acceptable to the Minister:

    • (a) the name and contact information of the manufacturer and, if the information is provided by the importer, the name and contact information of the importer;

    • (b) in the case of a Class II, III or IV device, the medical device licence number;

    • (c) the identifier of the device, 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;

    • (d) the name of the device, including, if applicable, the model name, in English and French;

    • (e) a description of the device and of its packaging and an indication of whether it is a single-use device;

    • (f) the date when the shortage began or is anticipated to begin;

    • (g) the anticipated date when the manufacturer will be able to meet the demand for the device if that date can be anticipated;

    • (h) the reason for the shortage; and

    • (i) a summary of the information that the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur.

  • (2) If the manufacturer of a specified medical device decides to discontinue the sale of the device in Canada, the following rules apply:

    • (a) the manufacturer or importer is required to provide only the information referred to in paragraphs (1)(a) to (f) in respect of the shortage that results from the decision and shall also provide under subsection (1) the reason for the discontinuation; and

    • (b) paragraph 4(a) does not apply to the manufacturer.

  • (3) For greater certainty, subsections (1) and (2) do not remove the requirement for a manufacturer that is the holder of a medical device licence to inform the Minister under subsection 43(3).

  • (4) Subject to subsection (8), the information that is required under subsection (1) shall be provided

    • (a) if the manufacturer or importer did not anticipate the shortage, within five business days after the day on which the manufacturer or importer becomes aware of it; and

    • (b) if the manufacturer or importer anticipates that there will be a shortage, within five business days after the day on which the manufacturer or importer anticipates it.

  • (5) If any of the information that was provided under subsection (1) changes, the manufacturer or importer shall provide the new information to the Minister electronically in a format specified by or acceptable to the Minister within two business days after the day on which the manufacturer or importer makes or becomes aware of the change.

  • (6) Within two business days after the day on which the manufacturer is again able to meet the demand for the specified medical device, the manufacturer or importer shall notify the Minister electronically in a format specified by or acceptable to the Minister of the manufacturer’s ability to do so.

  • (7) The manufacturer or importer need not provide the information that is required under subsection (1) if, within the applicable period referred to in paragraph (4)(a) or (b), the manufacturer or importer anticipates that the manufacturer will be able to meet the demand for the specified medical device within 30 days after the day on which the manufacturer or importer anticipated or became aware of the shortage.

  • (8) Despite subsection (7), if the manufacturer or importer subsequently concludes that the manufacturer will be unable to meet the demand within the 30-day period, the manufacturer or the importer shall provide the information that is required under subsection (1) within five business days after the day on which the manufacturer or importer reaches that conclusion.

  • (9) The manufacturer or importer need not provide the information that is required under subsection (1) if the manufacturer

    • (a) is also the manufacturer of another medical device that can be substituted for the specified medical device in respect of which a shortage exists or is likely to occur; and

    • (b) is able to meet the demand for the substitute medical device.

  •  (1) Despite section 62.23, the manufacturer of a specified medical device may permit the importer of the device to provide the information that is required under that section on the manufacturer’s behalf if the information that the manufacturer and importer must provide is identical.

  • (2) The manufacturer shall notify the Minister electronically in a format specified by or acceptable to the Minister if the manufacturer has permitted the importer to provide the information on the manufacturer’s behalf.

  •  (1) The Minister shall publish, on the Government of Canada website, the information that the Minister receives under section 62.23, other than the information referred to in subparagraph 62.23(1)(i).

  • (2) Subsection (1) does not apply if the Minister has reasonable grounds to believe that a situation, in respect of which information was provided under section 62.23, does not constitute a shortage.

  •  (1) The Minister may request that the manufacturer of a medical device — or any importer or distributor of a medical device — provide the Minister with information that is in their control if the Minister has reasonable grounds to believe that

    • (a) there is a shortage or risk of shortage of the device;

    • (b) a shortage of the device presents or may present a risk of injury to human health;

    • (c) the information is necessary to establish or assess

      • (i) the existence of a shortage or risk of shortage of the device,

      • (ii) the reason for a shortage or risk of shortage of the device,

      • (iii) the effects or potential effects on human health of a shortage of the device, or

      • (iv) measures that could be taken to prevent or alleviate a shortage of the device; and

    • (d) the manufacturer, importer or distributor will not provide the information without a legal obligation to do so.

  • (2) The manufacturer, importer or distributor shall provide the requested information electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister.

 The following definitions apply in this section and in sections 62.28 to 62.32.

designated medical device

designated medical device means a medical device that is set out in the List of Medical Devices for Exceptional Importation and Sale. (instrument médical désigné)

List of Medical Devices for Exceptional Importation and Sale

List of Medical Devices for Exceptional Importation and Sale means the List of Medical Devices for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux destinés aux importations et aux ventes exceptionnelles)

 The Minister may add a medical device to the List of Medical Devices for Exceptional Importation and Sale only if the Minister has reasonable grounds to believe that

  • (a) there is a shortage or risk of shortage of another medical device; and

  • (b) the device to be added to that list can be substituted for the device referred to in paragraph (a).

 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.

 Sections 21 to 21.2 and 26 do not apply to the importation, under section 62.29, of a designated medical device by the holder of an establishment licence.

  •  (1) The provisions of these Regulations — other than this section and sections 44 to 62.2, and 62.32 to 65.1 — do not apply to the sale of a designated medical device that is imported under section 62.29.

  • (2) Subsection (1) ceases to apply to the sale of a designated medical device on the earlier of

    • (a) the expiry date of the designated medical device, if the device has one, and

    • (b) the end of the two-year period that begins on the day that follows the date referred to in subparagraph 62.29(c)(vi).

  •  (1) The holder of an establishment licence shall not sell a designated medical device that they imported under section 62.29 unless they ensure that the information referred to in clause 62.29(a)(ii)(E) is available in English and French and in a manner that permits the safe use of the device.

  • (2) Subject to subsection (3), the holder shall ensure that the information is available in accordance with subsection (1) until at least the end of the day on the latest expiry date of the designated medical devices that they imported.

  • (3) If the designated medical device does not have an expiry date, the holder shall ensure that the information is available in accordance with subsection (1) until at least the expiration of the period that corresponds to the projected useful life of whichever of the devices that they imported has the latest projected useful life.

Recall

 Sections 64 and 65 do not apply to

  • (a) a retailer; or

  • (b) a health care facility in respect of a medical device that is distributed for use within that facility.

 The manufacturer and the importer of a medical device shall, on or before undertaking a recall of the device, each provide the Minister with the following:

  • (a) the name of the device and 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;

  • (b) the name and address of the manufacturer and importer, and the name and address of the establishment where the device was manufactured, if different from that of the manufacturer;

  • (c) the reason for the recall, the nature of the defectiveness or possible defectiveness and the date on and circumstances under which the defectiveness or possible defectiveness was discovered;

  • (d) an evaluation of the risk associated with the defectiveness or possible defectiveness;

  • (e) the number of affected units of the device that the manufacturer or importer

    • (i) manufactured in Canada,

    • (ii) imported into Canada, and

    • (iii) sold in Canada;

  • (f) the period during which the affected units of the device were distributed in Canada by the manufacturer or importer;

  • (g) the name of each person to whom the affected device was sold by the manufacturer or importer and the number of units of the device sold to each person;

  • (h) a copy of any communication issued with respect to the recall;

  • (i) the proposed strategy for conducting the recall, including the date for beginning the recall, information as to how and when the Minister will be informed of the progress of the recall and the proposed date for its completion;

  • (j) the proposed action to prevent a recurrence of the problem; and

  • (k) the name, title and telephone number of the representative of the manufacturer or importer to contact for any information concerning the recall.

 
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