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
AMENDMENTS NOT IN FORCE
— SOR/2025-246, s. 14
14 Subsection 3(2) of the Medical Devices RegulationsFootnote 2 is replaced by the following:
Return to footnote 2SOR/98-282
(2) Subsection (1) does not apply to
(a) a drug listed in Schedule E or F to the Act;
(b) a drug listed in any of the schedules to the Controlled Substances Regulations; or
(c) a drug containing cannabis, as those terms are defined in subsection 1(2) of the Cannabis Regulations and subsection 2(1) of the Cannabis Act, respectively.
— SOR/2026-96, s. 26
26 Section 43 of the Medical Devices RegulationsFootnote 2 is amended by adding the following after subsection (3):
Return to footnote 2SOR/98-282
(4) For greater certainty, subsection (3) does not remove the requirement for the holder of a medical device licence to post information under subsection 62.241(1).
— SOR/2026-96, s. 27
27 The heading before section 62.21 and sections 62.21 and 62.22 of the Regulations are replaced by the following:
Shortages and Discontinuation of Sale
62.21 (1) The following definitions apply in this section and in sections 62.22 to 62.25.
- List of Medical Devices — Shortages and Discontinuation of Sale
List of Medical Devices — Shortages and Discontinuation of Sale means the List of Medical Devices — Shortages and Discontinuation of Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux — pénuries et cessation de la vente)
- 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 — Shortages and Discontinuation of Sale. (instrument médical inscrit)
(2) In sections 62.23 and 62.241, designated website means
(a) if a hyperlink is on the Government of Canada website in accordance with section 62.25, the website that is maintained under contract with His Majesty in right of Canada; and
(b) if not, the part of the Government of Canada website that is represented as being for the purpose of posting information under sections 62.23 and 62.241.
62.211 Sections 62.23 to 62.242 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.
62.22 The Minister may add a category of medical devices to the List of Medical Devices — Shortages and Discontinuation of Sale only if the Minister has reasonable grounds to believe that a shortage, or discontinuation of sale in Canada, of any device that belongs to that category, if it were to occur, could present a risk of injury to human health.
— SOR/2026-96, s. 28
28 (1) The portion of subsection 62.23(1) of the Regulations before paragraph (b) is replaced by the following:
62.23 (1) Subject to subsections (5) and (7), 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 post the following information in English and French on the designated website:
(a) the name and contact information of the manufacturer and, if the information is posted by the importer, the name and contact information of the importer;
(2) Paragraph 62.23(1)(d) of the Regulations is replaced by the following:
(d) the name of the device, including, if applicable, the model name;
(3) Subsection 62.23(1) of the Regulations is amended by striking out “and” at the end of paragraph (h), by adding “and” at the end of paragraph (g) and by repealing paragraph (i).
(4) Subsections 62.23(2) to (9) of the Regulations are replaced by the following:
(2) Subject to subsection (6), the manufacturer or importer shall post the information
(a) if the manufacturer or importer anticipates that a shortage will begin in more than six months, at least six months before the day on which they anticipate it to begin;
(b) if the manufacturer or importer anticipates that a shortage will begin in six months or less, within five days after the day on which they make that determination; or
(c) if the manufacturer or importer did not anticipate the shortage, within five days after the day on which they become aware of it.
(3) If any of the information that was posted under subsection (1) changes, the manufacturer or importer shall update that information on the designated website within two days after the day on which the manufacturer or importer makes or becomes aware of the change.
(4) Within two 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 post information on the designated website to that effect.
(5) The manufacturer or importer is not required to post information on the designated website in respect of a specified medical device if, within the applicable period referred to in any of paragraphs (2)(a) to (c), the manufacturer or importer anticipates that the manufacturer will be able to meet the demand for the device within 30 days after
(a) the day on which the manufacturer or importer anticipates the shortage to begin; or
(b) if the manufacturer or importer did not anticipate the shortage, the day on which the shortage began.
(6) Despite subsection (5), if the manufacturer or importer subsequently determines that the manufacturer will be unable to meet the demand for the specified medical device within the 30-day period, the manufacturer or the importer shall post the information that is required under subsection (1) on the designated website within five days after the day on which the manufacturer or importer makes that determination.
(7) This section does not apply in respect of a shortage of a medical device that results from a decision by the manufacturer to discontinue its sale.
— SOR/2026-96, s. 29
29 Sections 62.24 and 62.25 of the Regulations are replaced by the following:
62.24 (1) Despite section 62.23, the manufacturer of a specified medical device may permit the importer of the device to post the information that is required under that section on the manufacturer’s behalf.
(2) The manufacturer shall notify the Minister, in the form and manner specified by the Minister, if the manufacturer has permitted the importer to post the information on the manufacturer’s behalf.
62.241 (1) Subject to subsection (5), if the manufacturer of a specified medical device or, in the case of a Class I device, the importer of the device decides to discontinue the sale of the device in Canada, the manufacturer or importer shall post the following information in English and French on the designated website:
(a) the name and contact information of the manufacturer and, if the information is posted by the importer, the name and contact information of the importer;
(b) in the case of a licensed device, the medical device licence number;
(c) in the case of a device for which the manufacturer holds an authorization issued under section 68.12, the authorization number;
(d) 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;
(e) the name of the device, including, if applicable, the model name;
(f) a description of the device and of its packaging and an indication of whether it is a single-use device; and
(g) the reason for the discontinuation of sale.
(2) For greater certainty, subsection (1) does not remove the requirement for
(a) a manufacturer that is the holder of a medical device licence to inform the Minister under subsection 43(3); or
(b) a manufacturer that is the holder of an authorization issued under section 68.12 to inform the Minister under section 68.25.
(3) The manufacturer or importer shall post the information
(a) if the manufacturer or importer decides to discontinue the sale of the device in more than 12 months, at least 12 months before the day on which they will discontinue its sale; and
(b) if the manufacturer or importer decides to discontinue the sale of the device in 12 months or less, within five days after the day on which they make that decision.
(4) If any of the information that was posted under subsection (1) changes, the manufacturer or importer shall update that information on the designated website within five days after the day on which the manufacturer or importer makes or becomes aware of the change.
(5) The manufacturer or importer is not required to post information on the designated website in respect of a specified medical device if the manufacturer
(a) is also the manufacturer of a new version of the device that is compatible with all of the components, parts and accessories of the device; and
(b) is able to meet the demand in Canada for the new version of the device.
62.242 (1) Despite section 62.241, the manufacturer of a specified medical device may permit the importer of the device to post the information that is required under that section on the manufacturer’s behalf.
(2) The manufacturer shall notify the Minister, in the form and manner specified by the Minister, if the manufacturer has permitted the importer to post the information on the manufacturer’s behalf.
62.25 If a person maintains a website under contract with His Majesty in right of Canada for the purpose of posting information under sections 62.23 and 62.241, the Minister shall ensure that a hyperlink to that website is on the Government of Canada website.
— SOR/2026-96, s. 39
39 Section 68.25 of the Regulations is renumbered as subsection 68.25(1) and is amended by adding the following:
(2) For greater certainty, subsection (1) does not remove the requirement for the holder to post information under subsection 62.241(1).
— SOR/2026-110, s. 1
1 Subsection 44(4) of the Medical Devices RegulationsFootnote 1 is replaced by the following:
Return to footnote 1SOR/98-282
(4) Subsection (3) does not apply to
(a) a person who imports a Class I medical device from the manufacturer of that device and who holds an establishment licence;
(b) a person who imports a Class II, III or IV medical device from the manufacturer of that device; or
(c) a person who imports any medical device from a person other than the manufacturer of that device and who holds an establishment licence.
— SOR/2026-110, s. 2
2 (1) Paragraph 45(e) of the Regulations is repealed.
(2) Section 45 of the Regulations is amended by adding the following after paragraph (f):
(f.1) the name and address of any person, other than the manufacturer, who sells a medical device to the establishment for the purposes of importation or distribution;
(f.2) for each person referred to in paragraph (f.1), other than the manufacturer, the classes of the devices that are being imported or distributed; and
(3) Paragraphs 45(g) to (i) of the Regulations are repealed.
(4) Paragraph 45(j) of the Regulations is replaced by the following:
(j) the address of each building where the procedures described in any of sections 52, 58, 58.1 and subsections 59(3) and (4) and 61.2(4) are in place.
— SOR/2026-110, s. 3
3 Subsection 46.1(1) of the Regulations is replaced by the following:
46.1 (1) The holder of an establishment licence that is not suspended must submit an application for the review of their licence to the Minister before April 1 of each year and include with it the information and documents referred to in section 45, including any updates to the information or documents, as the case may be.
— SOR/2026-110, s. 4
4 Section 52 of the Regulations is amended by adding the following after subsection (2):
(3) The manufacturer, importer and distributor of a medical device must each establish, implement and maintain documented procedures for maintaining the distribution records.
— SOR/2026-110, s. 5
5 The portion of section 58 of the Regulations before paragraph (a) is replaced by the following:
58 The manufacturer, importer and distributor of a medical device must each establish, implement and maintain documented procedures that enable them to carry out
— SOR/2026-110, s. 6
6 The Regulations are amended by adding the following after section 58:
Handling, Storage, Delivery, Installation, Servicing and Corrective Action
58.1 The manufacturer, importer and distributor of a Class II, III or IV medical device must each establish, implement and maintain documented procedures for, as applicable, the handling, storage, delivery, installation and servicing of the device and the taking of corrective action in respect of it.
— SOR/2026-110, s. 7
7 Section 59 of the Regulations is amended by adding the following after subsection (2):
(3) The manufacturer and importer of a Class I medical device must each establish, implement and maintain documented procedures for making any preliminary and final reports referred to in subsections (1) and (1.1).
(4) The manufacturer and importer of a Class II, III or IV medical device must each establish, implement and maintain documented procedures for making any preliminary and final reports referred to in subsection (1).
— SOR/2026-110, s. 8
8 Section 61.2 of the Regulations is amended by adding the following after subsection (3):
(4) The holder of a medical device licence and the importer of a Class II, III or IV medical device must each establish, implement and maintain documented procedures that enable the effective and timely provision of information referred to in subsection (2).
— SOR/2026-110, s. 9
9 (1) Unless the context requires otherwise, the words and expressions used in this section have the same meaning as in the Medical Devices Regulations.
(2) A person who has submitted an application for an establishment licence under section 45 of the Medical Devices Regulations, as it read before the day on which these Regulations come 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 paragraphs 45(f.1) and (f.2) of those Regulations, as amended by these Regulations.
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