Medical Devices Regulations (SOR/98-282)
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Regulations are current to 2025-12-10 and last amended on 2025-05-31. Previous Versions
PART 1General (continued)
Shortages (continued)
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; and
(b) the device to be added to that list can be substituted for the device referred to in paragraph (a).
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.
62.3 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.
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).
62.32 (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 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.
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.
65 A manufacturer or importer of a medical device shall, within 30 days after completing a recall of the device that was not ordered by the Minister, provide the Minister with the following information, in writing:
(a) the results of the recall; and
(b) the action taken to prevent a recurrence of the problem.
65.1 (1) A manufacturer of a medical device who recalls the device without being ordered to do so by the Minister may permit the importer of the device to prepare and submit, on the manufacturer’s behalf, the information and documents that are required to be provided under sections 63.2, 64 and 65 if the information and documents that the manufacturer and importer must submit are identical.
(2) The manufacturer shall advise the Minister in writing if the manufacturer has permitted the importer to prepare and submit the information and documents referred to in subsection (1) on the manufacturer’s behalf.
- SOR/2002-190, s. 6
- SOR/2024-136, s. 18
65.2 (1) A person who is ordered by the Minister to recall a medical device shall provide the Minister with the following information in the time and manner specified by the Minister:
(a) the name and address of
(i) the manufacturer of the device,
(ii) the establishment where the device was manufactured, if different from that of the manufacturer,
(iii) the importer of the device, and
(iv) the person who sold them the device, if the person who is conducting the recall is not the manufacturer;
(b) 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;
(c) the number of affected units of the device that the person
(i) manufactured in Canada,
(ii) imported into Canada, and
(iii) sold in Canada;
(d) the number of affected units of the device in Canada that are in the possession or control of the person;
(e) the period during which the affected units of the device were distributed in Canada by the person;
(f) the number of affected units of the device that have been sold by the person at the retail level to consumers in Canada;
(g) if the person has sold the affected device to persons in Canada other than consumers referred to in paragraph (f), the names of those persons and the number of units of the device sold to each of them;
(h) 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;
(i) the proposed action to prevent a recurrence of the problem;
(j) the name, title and contact information of the representative of the person to contact for information concerning the recall; and
(k) any other information that the Minister has reasonable grounds to believe is necessary to reduce the risk of injury to health.
(2) The person shall notify the Minister without delay of any change to the information referred to in paragraph (1)(j).
(3) The person shall
(a) before beginning the recall, provide the Minister with a copy of any communications that the person intends to use in connection with beginning the recall; and
(b) after beginning the recall, provide the Minister with, on request and within the time specified by the Minister, a copy of any additional communications that the person uses, or intends to use in connection with the recall.
(4) The person shall notify the Minister in writing, within 24 hours, of the beginning and completion of the recall.
(5) The person shall, within 30 days after completing the recall, provide the Minister with the following information in writing:
(a) the results of the recall; and
(b) the action taken to prevent a recurrence of the problem.
Record Keeping
65.3 A manufacturer or importer of a medical device who recalls the device without being ordered to do so by the Minister shall keep a record of the following:
(a) a document that sets out the decision to conduct the recall, including
(i) the name and title of the individual who made the decision, and
(ii) the date the decision was made;
(b) the date the recall was completed;
(c) the information and documents referred to in sections 63.2, 64 and 65; and
(d) the document provided to the Minister under subsection 65.1(2), if applicable.
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