Government of Canada / Gouvernement du Canada
Symbol of the Government of Canada

Search

Medical Devices Regulations (SOR/98-282)

Regulations are current to 2021-01-10 and last amended on 2019-12-16. Previous Versions

AMENDMENTS NOT IN FORCE

  • — SOR/2020-262, s. 6

      • 6 (1) The definition système de gestion de la qualité in section 1 of the French version of the Medical Devices RegulationsFootnote 2 is replaced by the following:

        French version only

        système de gestion de la qualité Vaut mention de l’expression « système de management de la qualité » figurant à la norme nationale du Canada CAN/CSA-ISO 13485 intitulée Dispositifs médicaux — Systèmes de management de la qualité — Exigences à des fins réglementaires, avec ses modifications successives. (French version only)

      • (2) Section 1 of the Regulations is amended by adding the following in alphabetical order:

        regulatory agency

        regulatory agency means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of medical devices within its jurisdiction and that may take enforcement action to ensure that medical devices marketed within its jurisdiction comply with the applicable legal requirements. (organisme de réglementation)

  • — SOR/2020-262, s. 7

      • 7 (1) Subsection 25(1) of the Regulations is replaced by the following:

          • 25 (1) If the Minister believes on reasonable grounds, after reviewing a report or information brought to his or her attention, that a Class I medical device may not meet the applicable requirements of sections 10 to 20, the Minister may request the manufacturer to submit, on or before the day specified in the request, an analysis or other information to enable him or her to determine whether the device meets those requirements.

      • (2) The portion of subsection 25(2) of the Regulations before paragraph (b) is replaced by the following:

        • (2) The Minister may direct the manufacturer to stop the sale of the medical device if

          • (a) the manufacturer has not complied with the request on or before the day specified in the request; or

      • (3) Paragraph 25(2)(b) of the English version of the Regulations is replaced by the following:

        • (b) the Minister determines, on the basis of the information submitted, that the device does not meet the applicable requirements of sections 10 to 20.

      • (4) The portion of subsection 25(3) of the Regulations before paragraph (c) is replaced by the following:

        • (3) The Minister shall lift the direction to stop the sale if

          • (a) the Minister determines, on the basis of the information submitted, that the medical device meets the applicable requirements of sections 10 to 20;

          • (b) corrective action has been taken to ensure that the medical device meets the applicable requirements of sections 10 to 20; or

  • — SOR/2020-262, s. 8

      • 8 (1) Paragraph 32(2)(f) of the Regulations is replaced by the following:

        • (f) a copy of the quality management system certificate certifying that the quality management system under which the device is manufactured meets the requirements set out in the National Standard of Canada CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, as amended from time to time.

      • (2) Paragraph 32(3)(j) of the Regulations is replaced by the following:

        • (j) a copy of the quality management system certificate certifying that the quality management system under which the device is designed and manufactured meets the requirements set out in the National Standard of Canada CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, as amended from time to time.

      • (3) Paragraph 32(4)(p) of the Regulations is replaced by the following:

        • (p) a copy of the quality management system certificate certifying that the quality management system under which the device is designed and manufactured meets the requirements set out in the National Standard of Canada CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, as amended from time to time.

  • — SOR/2020-262, s. 9

    • 9 Section 39 of the Regulations and the heading before it are replaced by the following:

      Requests by Minister
      • 39 If the Minister believes on reasonable grounds, after reviewing a report or information brought to his or her attention, that a licensed medical device may not meet the applicable requirements of sections 10 to 20, the Minister may request the manufacturer to submit, on or before the day specified in the request, samples — or an analysis or other information — to enable him or her to determine whether the device meets those requirements.

  • — SOR/2020-262, s. 10

    • 10 Paragraph 40(1)(d) of the Regulations is replaced by the following:

      • (d) the licensee has not complied with a request made under section 39 on or before the day specified in the request;

      • (d.1) the samples — or the analysis or other information — submitted by the licensee in response to a request made under section 39 are insufficient to enable the Minister to determine whether the medical device meets the applicable requirements of sections 10 to 20;

  • — SOR/2020-262, s. 11

    • 11 The Regulations are amended by adding the following after section 41:

      • 41.1 The Minister may suspend a medical device licence if, after he or she has, under section 21.31 of the Act, ordered the licensee to conduct an assessment of the medical device in order to provide evidence establishing that the benefits associated with the device outweigh the risks to the health or safety of patients, users or other persons,

        • (a) the licensee has not complied with the order; or

        • (b) the licensee has complied with the order but the Minister determines that the results of the assessment are not sufficient to establish that the benefits associated with the device outweigh the risks to the health or safety of patients, users or other persons.

  • — SOR/2020-262, s. 12

    • 12 Paragraph 45(h) of the Regulations is replaced by the following:

      • (h) if the establishment imports Class I medical devices, an attestation by a senior official of the establishment that the establishment has documented procedures in place in respect of the making of reports under subsections 59(1) and (1.1);

      • (h.1) if the establishment imports Class II, III or IV medical devices, an attestation by a senior official of the establishment that the establishment has documented procedures in place in respect of the making of reports under subsection 59(1) and the provision of information under section 61.2;

  • — SOR/2020-262, s. 13

    • 13 The heading before section 59 of the Regulations is replaced by the following:

      Incident Reporting

  • — SOR/2020-262, s. 14

    • 14 Subsection 59(1) of the Regulations is replaced by the following:

        • 59 (1) The manufacturer and the importer of a medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes to their attention occurring in Canada that involves the device if

          • (a) the device is sold in Canada; and

          • (b) the incident

            • (i) is related to a failure of the device or a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use, and

            • (ii) has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were the incident to recur.

        • (1.1) Subject to subsection (2), the manufacturer and the importer of a Class I medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes to their attention occurring outside Canada that involves the device if the conditions in paragraphs (1)(a) and (b) are met.

  • — SOR/2020-262, s. 15

    • 15 Subsection 61.1(1) of the Regulations is replaced by the following:

        • 61.1 (1) Despite subsection 59(1) or (1.1), the manufacturer of a medical device may permit the importer of the device to prepare and submit the preliminary and final reports on the manufacturer’s behalf if the information that the manufacturer and the importer must include is identical.

  • — SOR/2020-262, s. 16

    • 16 The Regulations are amended by adding the following after section 61.1:

      Serious Risk of Injury to Human Health

        • 61.2 (1) This section applies to a holder of one of the following therapeutic product authorizations:

          • (a) a medical device licence; and

          • (b) an establishment licence to import Class II, III or IV medical devices.

        • (2) The holder of a therapeutic product authorization issued in respect of a medical device shall submit to the Minister information in respect of any serious risk of injury to human health that the holder receives or becomes aware of and that is relevant to the safety of the device, regarding

          • (a) risks that have been communicated by any regulatory agency that is set out in the List of Regulatory Agencies for the Purposes of Section 61.2 of the Medical Devices Regulations, published by the Government of Canada on its website, as amended from time to time, or by any person who is authorized to manufacture or sell a medical device within the jurisdiction of such a regulatory agency, and the manner of the communication;

          • (b) changes that have been made to the labelling of any medical device and that have been communicated to or requested by any regulatory agency that is set out in the list referred to in paragraph (a); and

          • (c) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of any medical device, that have taken place within the jurisdiction of any regulatory agency that is set out in the list referred to in paragraph (a).

        • (3) The information shall be submitted to the Minister within 72 hours after the holder receives or becomes aware of it, whichever occurs first.

        • 61.3 (1) Despite subsection 61.2(2), if the holder of a therapeutic product authorization issued in respect of a medical device is the manufacturer, they may permit the importer of the device to submit the information required under that subsection on the manufacturer’s behalf if the information that the manufacturer and the importer must submit is identical.

        • (2) The manufacturer shall advise the Minister in writing if the manufacturer has permitted the importer to submit the information on the manufacturer’s behalf.

      Summary Report

        • 61.4 (1) The holder of a medical device licence shall prepare

          • (a) in the case of a Class II medical device, on a biennial basis, a summary report of the information that pertains to the matters referred to in subsection (2) and that the licensee received or became aware of during the previous 24 months; and

          • (b) in the case of a Class III or IV medical device, on an annual basis, a summary report of the information that pertains to the matters referred to in subsection (2) and that the licensee received or became aware of during the previous 12 months.

        • (2) The matters to be covered by the summary report are

          • (a) adverse effects;

          • (b) problems referred to in paragraph 57(1)(a);

          • (c) incidents referred to in subsection 59(1); and

          • (d) serious risks of injury to human health that are relevant to the safety of the medical device and are referred to in subsection 61.2(2).

        • (3) The summary report shall contain a concise critical analysis of the information referred to in subsection (1).

        • (4) In preparing the summary report, the licensee shall determine, on the basis of the analysis referred to in subsection (3), whether what is known about the benefits and risks associated with the medical device has changed as described in any of the following paragraphs:

          • (a) any of the benefits that may be obtained by patients through the use of the medical device could be less;

          • (b) in respect of any of the risks,

            • (i) the risk is more likely to occur, or

            • (ii) if the risk occurs, the consequences for the health or safety of patients, users or other persons could be more serious; and

          • (c) a new risk has been identified.

        • (5) The licensee shall include the conclusions they reach under subsection (4) in the summary report.

        • (6) If, in preparing the summary report, the licensee concludes that what is known about the benefits and risks associated with the medical device has changed as described in any of paragraphs (4)(a) to (c), they shall notify the Minister, in writing, within 72 hours after having reached the conclusion, unless that has already been done.

        • 61.5 (1) The Minister may, for the purposes of determining whether a medical device meets the applicable requirements of sections 10 to 20, request that the holder of a medical device licence issued in respect of the device submit, on or before the day specified in the request, any of the following:

          • (a) summary reports; or

          • (b) information on the basis of which summary reports were prepared.

        • (2) The licensee shall submit to the Minister the summary reports or information, or both, that the Minister requests not later than the day specified in the request.

        • 61.6 (1) The holder of a medical device licence shall maintain records of the summary reports and the information on the basis of which those reports were prepared.

        • (2) The licensee shall retain the records for seven years after the day on which they were created.

  • — SOR/2020-262, s. 17

    • 17 The Regulations are amended by adding the following after section 62:

      Assessments Ordered Under Section 21.31 of the Act

        • 62.1 (1) The Minister’s power to make an order under section 21.31 of the Act in respect of a medical device is subject to the following conditions:

          • (a) the person to whom the order is made shall be the holder of a medical device licence issued in respect of the device; and

          • (b) the Minister shall have reasonable grounds to believe that the benefits — or the risks to the health or safety of patients, users or other persons — that are associated with the device are significantly different than they were when the medical device licence was issued or amended.

        • (2) The Minister shall, after examining the results of an assessment that was ordered under section 21.31 of the Act in respect of a medical device,

          • (a) provide the holder of the medical device licence issued in respect of the device with the results of the examination; and

          • (b) ensure that a summary of the results of the examination, together with a description of any steps that the Minister has taken or may take as a consequence of the examination, is published on the Government of Canada website.

      Activities Ordered Under Section 21.32 of the Act

      • 62.2 The Minister’s power to make an order under section 21.32 of the Act in respect of a medical device is subject to the following conditions:

        • (a) the person to whom the order is made shall be the holder of a medical device licence issued in respect of the device;

        • (b) the Minister shall have reasonable grounds to believe that

          • (i) there are significant uncertainties relating to the benefits or adverse effects associated with the device,

          • (ii) the licensee is unable to provide the Minister with information that is sufficient to manage those uncertainties, and

          • (iii) the applicable requirements of these Regulations, together with any terms and conditions that have been imposed on the medical device licence, do not allow for sufficient information to be obtained to manage those uncertainties; and

        • (c) the Minister shall take into account the following matters:

          • (i) whether the activities that the licensee will be ordered to undertake are feasible, and

          • (ii) whether there are less burdensome ways of obtaining additional information about the device’s effects on the health or safety of patients, users or other persons.

  • — SOR/2020-262, s. 18

    • 18 The heading before section 77 of the English version of the Regulations is replaced by the following:

      Incident Reporting

  • — SOR/2020-262, s. 19

    • 19 Section 77 of the Regulations is replaced by the following:

      • 77 The health care professional referred to in subsection 71(1) shall, within 72 hours after becoming aware of an incident that involves the medical device for which an authorization has been issued under section 72 and that meets the following conditions, report the incident to the Minister and to the manufacturer or importer of the device and specify the nature of the incident and the circumstances surrounding it:

        • (a) the incident is related to a failure of the device or a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use; and

        • (b) the incident has led to the death or a serious deterioration in the state of health of a patient, user or other person or could do so were the incident to recur.

  • — SOR/2020-262, s. 20

    • 20 Subparagraph 81(k)(v) of the Regulations is replaced by the following:

      • (v) in the event of an incident involving the device and that meets the following conditions, report the incident and the circumstances surrounding it to the Minister and to the manufacturer or importer of the device within 72 hours after the qualified investigator becomes aware of the incident:

        • (A) the incident is related to a failure of the device or a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use, and

        • (B) the incident has led to the death or a serious deterioration in the state of health of a patient, user or other person or could do so were the incident to recur.

  • — SOR/2020-262, s. 21

    • 21 Paragraph 88(c) of the Regulations is replaced by the following:

      • (c) sections 59 to 61.1 with respect to reports on incidents;

  • — SOR/2020-262, s. 22

    • 22 The Regulations are amended by adding the following after section 88:

      • 88.1 Subsections 61.2(2) and (3) and section 61.3 apply in respect of medical devices to which this Part applies except that the references to a holder of a therapeutic product authorization in those provisions shall be read as references to a holder of an authorization issued under subsection 83(1).

Date modified: