Medical Devices Regulations (SOR/98-282)
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Regulations are current to 2024-11-26 and last amended on 2024-01-03. Previous Versions
AMENDMENTS NOT IN FORCE
— SOR/2024-110, s. 83
83 The Medical Devices RegulationsFootnote 2 are amended by adding the following after section 2:
Return to footnote 2SOR/98-282
2.1 For greater certainty, these Regulations apply to a medical device that is a drug referred to in paragraph (b) or (c) of the definition biocide in subsection 1(1) of the Biocides Regulations.
— SOR/2024-136, s. 6
6 The definition recall in section 1 of the Medical Devices RegulationsFootnote 2 is replaced by the following:
Return to footnote 2SOR/98-282
- recall
recall means
(a) a recall ordered by the Minister under section 21.3 of the Act; or
(b) any action taken by a manufacturer, importer or distributor of a medical device, after the device has been sold, to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device
(i) may present a risk of injury to health,
(ii) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety, or
(iii) may not meet the requirements of the Act or these Regulations. (rappel)
— SOR/2024-136, s. 7
7 Paragraph 45(b) of the Regulations is replaced by the following:
(a.1) any other name under which the person previously conducted activities under these Regulations;
(b) the name, title and contact information of the representative of the establishment to contact for information concerning the application;
— SOR/2024-136, s. 8
8 Section 48 of the English version of the Regulations is replaced by the following:
48 If, following the issuance of an establishment licence, there is a change to any of the information referred to in paragraph 45(a) or (b), the holder of the establishment licence shall submit the new information to the Minister within 15 days of the change.
— SOR/2024-136, s. 9
9 The Regulations are amended by adding the following after section 48:
Terms and Conditions
48.1 The Minister may, at any time, impose terms and conditions on an establishment licence, or amend those terms and conditions, after considering the following factors:
(a) whether there are uncertainties relating to the manner in which an activity is or will be conducted;
(b) whether the requirements under the Act are sufficient to protect patients, users or other persons from risks to health or safety;
(c) whether compliance with the proposed terms and conditions is feasible; and
(d) whether there are less burdensome ways to meet the objectives of the proposed terms and conditions.
— SOR/2024-136, s. 10
10 Section 53 of the Regulations is replaced by the following:
53 The distribution record shall contain sufficient information to permit the complete and rapid recall of the medical device.
— SOR/2024-136, s. 11
11 Subsection 62.31(1) of the Regulations is replaced by the following:
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.
— SOR/2024-136, s. 12
12 The heading before section 63 of the English version of the Regulations is replaced by the following:
Recalls
— SOR/2024-136, s. 13
13 The Regulations are amended by adding the following before section 63:
Recall Reporting
— SOR/2024-136, s. 14
14 The portion of section 63 of the Regulations before paragraph (a) is replaced by the following:
63 Sections 63.2, 64 and 65 do not apply to
— SOR/2024-136, s. 15
15 The Regulations are amended by adding the following after section 63:
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.
— SOR/2024-136, s. 16
16 Section 64 of the Regulations is replaced by the following:
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.
— SOR/2024-136, s. 17
17 The portion of section 65 of the Regulations before paragraph (a) is replaced by the following:
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:
— SOR/2024-136, s. 18
18 Section 65.1 of the Regulations is replaced by the following:
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.
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.
65.4 (1) Subject to subsection (2), a distributor of a medical device who conducts a recall of the device that was not ordered by the Minister shall keep a record of the following:
(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,
(iii) the importer, and
(iv) the person who sold them the device;
(f) the reason for the recall, the nature of the defectiveness or potential defectiveness of the device and the date on which and circumstances under which the defectiveness or potential defectiveness was discovered;
(g) the number of affected units of the device that the distributor sold in Canada;
(h) the period during which the affected units of the device were distributed in Canada by the distributor;
(i) the name of each person to whom the affected device was sold by the distributor and the number of units of the device sold to each person;
(j) a copy of any communication issued with respect to the recall;
(k) the results of the recall; and
(l) the date the recall was completed.
(2) A distributor who initiates the recall shall keep a record of the following:
(a) the information and documents referred to in subsection (1);
(b) an evaluation of the risk associated with the defectiveness or potential defectiveness of the medical device to which the recall relates; and
(c) the actions that were proposed and actions taken to prevent a recurrence of the problem.
65.5 A person who is ordered by the Minister to recall a medical device shall keep a record of the information and documents provided to the Minister under section 65.2.
65.6 (1) A manufacturer who is required to keep a record under section 65.3 or 65.5 shall keep it for at least the longer of the following periods:
(a) the period that is equivalent to the projected useful life of the medical device to which the recall relates plus two years; and
(b) the period during which the device is sold in Canada.
(2) Any other person who is required to keep a record under section 65.3, 65.4 or 65.5 shall keep it for at least a period equivalent to the projected useful life of the device to which the recall relates plus two years.
(3) For the purpose of paragraph (1)(a) and subsection (2), the retention period begins on the day on which the recall is completed.
— SOR/2024-136, s. 19
19 Paragraph 68.03(2)(c) of the Regulations is replaced by the following:
(c) sections 21, 23, 27, 52 to 58, 62 and 62.21 to 65.6.
— SOR/2024-136, s. 20
20 Paragraph 88(d) of the Regulations is replaced by the following:
(d) sections 63 to 65.6 with respect to recalls; and
— SOR/2024-136, s. 21
21 Unless the context requires otherwise, the words and expressions used in sections 22 and 23 have the same meaning as in the Medical Devices Regulations.
— SOR/2024-136, s. 22
22 A person who has submitted an application for an establishment licence under section 45 of the Medical Devices Regulations before the day on which section 7 comes into force and in respect of which no decision has been made before that day must not be issued the licence unless, by that day and in the form established by the Minister, the person provides the Minister with the information referred to in paragraph 45(b) of the Medical Devices Regulations, as amended by these Regulations.
— SOR/2024-136, s. 23
23 The holder of an establishment licence that was issued under section 46 of the Medical Devices Regulations before the day on which section 7 comes into force must, by that day and in the form established by the Minister, provide the Minister with the contact information, other than the telephone number, of the representative of the establishment to contact for information concerning the licence.
- Date modified: