Medical Devices Regulations (SOR/98-282)
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Regulations are current to 2026-06-17 and last amended on 2026-06-17. Previous Versions
PART 1General (continued)
Shortages (continued)
62.24 (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.
62.25 (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.
62.26 (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, if it were to occur, could 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,
(iv) measures that could be taken to prevent or mitigate shortage risks associated with the device, or
(v) measures that could be taken to mitigate the impacts of 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 in the time, form and manner specified by the Minister.
62.27 The following definitions apply in this section and in sections 62.28 to 62.321.
- 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)
62.28 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;
(a.1) a shortage of the device referred to in paragraph (a), if it were to occur, could present a risk of injury to human health;
(b) the device to be added to that list can be substituted for the device referred to in paragraph (a); and
(c) the device to be added to that list is authorized to be sold by a regulatory agency within its jurisdiction or, if the sale of the device is not required to be authorized by a regulatory agency within its jurisdiction, the device complies with the applicable legal requirements within the agency’s jurisdiction.
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.
62.3 Sections 21.1 and 21.2 do not apply in respect of the importation of a designated medical device under section 62.29.
62.31 (1) The provisions of these Regulations — other than this section and sections 44 to 62.2 and 62.32 to 65.6 — 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).
62.311 (1) No person shall sell a designated medical device that is intended to be sold to the general public on a retail basis unless the information referred to in clause 62.29(a)(ii)(E) is available in English and French to the purchaser or consumer in any of the following manners:
(a) the information accompanies the device;
(b) the information is provided in writing to the purchaser or consumer at the time of sale;
(c) in the case where the device is accessible to the public for self-selection, copies of the information are placed adjacent to the device in a manner that permits the purchaser or consumer to take one.
(2) For the purposes of subsection (1), the English and French versions of the information referred to in clause 62.29(a)(ii)(E) need not be available in the same manner.
62.32 (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 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.
62.321 If the holder of an establishment licence receives or becomes aware of the following information in respect of a designated medical device that they imported under section 62.29, the holder shall notify the Minister, in the form and manner specified by the Minister, no later than 72 hours after they receive or become aware of the information, whichever occurs first:
(a) the device is not authorized to be sold by the regulatory agency referred to in paragraph 62.28(d); or
(b) if the sale of the device is not required to be authorized by the regulatory agency referred to in paragraph 62.28(d), the device may not meet the applicable legal requirements within the agency’s jurisdiction.
62.322 (1) Section 61.2 applies — in respect of a designated medical device — to a person who holds an establishment licence and imports the medical device under section 62.29, with any necessary modifications.
(2) A reference to a regulatory agency in paragraphs 61.2(2)(a) to (c) includes a reference to the regulatory agency referred to in paragraph 62.28(c) if that regulatory agency is not set out in the List of Regulatory Agencies for the Purposes of Sections 61.2 and 68.3 of the Medical Devices Regulations, published by the Government of Canada on its website, as amended from time to time.
62.323 A medical device that is removed from the List of Medical Devices for Exceptional Importation and Sale before the date referred to in subsection 62.32(2) or the expiration of the period referred to in subsection 62.32(3), as the case may be, continues to be considered a designated medical device for the purposes of sections 62.32 to 62.322 until that date or the expiration of that period.
Recalls
- SOR/2024-136, s. 12(E)
Recall Reporting
- SOR/2024-136, s. 13
63 Sections 63.2, 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.
63.1 Sections 63.2, 64 and 65 do not apply to a manufacturer or importer of a medical device unless the device is likely to cause injury to the health of a patient, user or other person, or could cause serious injury to the health of a patient, user or other person.
63.2 A manufacturer or importer of a medical device who decides to recall the device without being ordered to do so by the Minister shall provide the Minister with the following information, in writing, within 24 hours after making the decision:
(a) the name of the device;
(b) 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;
(c) in the case of a licensed device, the medical device licence number;
(d) in the case of a device for which the manufacturer holds an authorization issued under section 68.12, the authorization number;
(e) the name and address of
(i) the manufacturer,
(ii) the establishment where the device was manufactured, if different from that of the manufacturer, and
(iii) the importer;
(f) the reason for the recall, the nature of the defectiveness or potential defectiveness of the device and the date on which and the circumstances under which the defectiveness or potential defectiveness was discovered; and
(g) a preliminary evaluation of the risk associated with the defectiveness or potential defectiveness of the device.
64 A manufacturer or importer of a medical device shall, on or before the day on which the manufacturer or importer begins a recall of the device that has not been ordered by the Minister, provide the Minister with the following information and documents in writing:
(a) the name of the device;
(b) 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;
(c) in the case of a licensed device, the medical device licence number;
(d) in the case of a device for which the manufacturer holds an authorization issued under section 68.12, the authorization number;
(e) the name and address of
(i) the manufacturer,
(ii) the establishment where the device was manufactured, if different from that of the manufacturer, and
(iii) the importer;
(f) the reason for the recall, the nature of the defectiveness or potential defectiveness of the device and the date on which and the circumstances under which the defectiveness or potential defectiveness was discovered;
(g) an evaluation of the risk associated with the defectiveness or potential defectiveness of the device;
(h) 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;
(i) the period during which the affected units of the device were distributed in Canada by the manufacturer or importer;
(j) 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;
(k) a copy of any communication issued with respect to the recall;
(l) the proposed strategy for conducting the recall, including
(i) the date for beginning the recall,
(ii) the time and manner in which the Minister will be informed of the progress of the recall, and
(iii) the proposed date of its completion;
(m) the proposed action to prevent a recurrence of the problem; and
(n) the name, title and contact information of the representative of the manufacturer or importer to contact for information concerning the recall.
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