Medical Devices Regulations (SOR/98-282)

• 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, within a specified time limit, any of the following:

  • (a) summary reports; or

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

• (2) The holder shall submit to the Minister the summary reports or information, or both, that the Minister requests within the time limit 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 holder shall retain the records for seven years after the day on which they were created.

Provision of Information Under Section 21.8 of Act

• 62 (1) For the purposes of section 21.8 of the Act, hospitals are the prescribed health care institutions that shall provide information that is in their control to the Minister about a medical device incident.

• (2) The following prescribed information about a medical device incident that is in a hospital’s control shall be provided to the Minister in writing within 30 days after the day on which the medical device incident is first documented within the hospital:

  • (a) the name of the hospital and the contact information of a representative of that hospital;

  • (b) the name or identifier of the medical device;

  • (c) the date on which the medical device incident was first documented;

  • (d) the name of the manufacturer of the medical device;

  • (e) a description of the medical device incident;

  • (f) the lot number of the device or its serial number;

  • (g) any contributing factors to the medical device incident, including any medical condition of the patient that directly relates to the medical device incident; and

  • (h) the effect of the medical device incident on the patient’s health.

• (3) A hospital is exempt from section 21.8 of the Act in respect of the reporting of information referred to in subsection (2) if

  • (a) the hospital does not have in its control all of the information referred to in paragraphs (2)(b) and (e) in respect of the medical device incident; or

  • (b) the medical device incident involves only a medical device that is the subject of an authorization issued under subsection 72(1) or 83(1).

• (4) The following definitions apply in this section.

  hospital

  hospital means a facility

  • (a) that is licensed, approved or designated as a hospital by a province in accordance with the laws of the province to provide care or treatment to persons suffering from any form of disease or illness; or

  • (b) that is operated by the Government of Canada and that provides health services to in-patients. (hôpital)

  medical device incident

  medical device incident means an incident related to a failure of a medical device, a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use that 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 it to recur. (incident lié à un instrument médical)

• (5) For the purposes of the Act, medical device incident has the same meaning as in subsection (4).

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.

Shortages

62.21 The following definitions apply in this section and in sections 62.22 to 62.26.

List of Medical Devices – Notification of Shortages

List of Medical Devices – Notification of Shortages means the List of Medical Devices – Notification of Shortages that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux – avis de pénuries)

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 – Notification of Shortages. (instrument médical inscrit)

62.22 The Minister may add a category of medical devices to the List of Medical Devices – Notification of Shortages only if the Minister has reasonable grounds to believe that a shortage of a device that belongs to the category presents or may present a risk of injury to human health.

• 62.23 (1) Subject to subsections (2), (7) and (9), 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 provide the following information to the Minister electronically in a format specified by or acceptable to the Minister:

  • (a) the name and contact information of the manufacturer and, if the information is provided by the importer, the name and contact information of the importer;

  • (b) in the case of a licensed device, the medical device licence number;

  • (b.1) in the case of a device for which the manufacturer holds an authorization issued under section 68.12, the authorization number;

  • (c) 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;

  • (d) the name of the device, including, if applicable, the model name, in English and French;

  • (e) a description of the device and of its packaging and an indication of whether it is a single-use device;

  • (f) the date when the shortage began or is anticipated to begin;

  • (g) the anticipated date when the manufacturer will be able to meet the demand for the device if that date can be anticipated;

  • (h) the reason for the shortage; and

  • (i) a summary of the information that the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur.

• (2) If the manufacturer of a specified medical device decides to discontinue the sale of the device in Canada, the following rules apply:

  • (a) the manufacturer or importer is required to provide only the information referred to in paragraphs (1)(a) to (f) in respect of the shortage that results from the decision and shall also provide under subsection (1) the reason for the discontinuation; and

  • (b) paragraph 4(a) does not apply to the manufacturer.

• (3) For greater certainty, subsections (1) and (2) do 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.

• (4) Subject to subsection (8), the information that is required under subsection (1) shall be provided

  • (a) if the manufacturer or importer did not anticipate the shortage, within five business days after the day on which the manufacturer or importer becomes aware of it; and

  • (b) if the manufacturer or importer anticipates that there will be a shortage, within five business days after the day on which the manufacturer or importer anticipates it.

• (5) If any of the information that was provided under subsection (1) changes, the manufacturer or importer shall provide the new information to the Minister electronically in a format specified by or acceptable to the Minister within two business days after the day on which the manufacturer or importer makes or becomes aware of the change.

• (6) Within two business 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 notify the Minister electronically in a format specified by or acceptable to the Minister of the manufacturer’s ability to do so.

• (7) The manufacturer or importer need not provide the information that is required under subsection (1) if, within the applicable period referred to in paragraph (4)(a) or (b), the manufacturer or importer anticipates that the manufacturer will be able to meet the demand for the specified medical device within 30 days after the day on which the manufacturer or importer anticipated or became aware of the shortage.

• (8) Despite subsection (7), if the manufacturer or importer subsequently concludes that the manufacturer will be unable to meet the demand within the 30-day period, the manufacturer or the importer shall provide the information that is required under subsection (1) within five business days after the day on which the manufacturer or importer reaches that conclusion.

• (9) The manufacturer or importer need not provide the information that is required under subsection (1) if the manufacturer

  • (a) is also the manufacturer of another medical device that can be substituted for the specified medical device in respect of which a shortage exists or is likely to occur; and

  • (b) is able to meet the demand for the substitute medical device.

• 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 presents or may 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, or

    • (iv) measures that could be taken to prevent or alleviate 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 electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister.

62.27 The following definitions apply in this section and in sections 62.28 to 62.32.

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)