Medical Devices Regulations (SOR/98-282)

68.37 The Minister shall publish on the Government of Canada website supplementary information pertaining to the expanded use, set out in column 3 of the List of Medical Devices for Expanded Use, of a licensed medical device — or a Class II, III or IV medical device for which the manufacturer holds an authorization —, set out in column 2 of that list, including

• (a) a statement of the expanded use;

• (b) a statement of the known and potential benefits and risks; and

• (c) any supplement to the directions for use, unless a supplement is not required for the device to be used safely and effectively.

• 68.38 (1) The Minister may request from the holder of a medical device licence, in respect of the medical device that is set out in column 2 of the List of Medical Devices for Expanded Use for which the licence was issued, any information in relation to the expanded use that is set out in column 3 of that list that the holder possesses or to which they have reasonable access.

• (2) The Minister may request from the holder of an authorization, in respect of the Class II, III or IV medical device set out in column 2 of the List of Medical Devices for Expanded Use for which the authorization was issued, any information in relation to the expanded use set out in column 3 of that list that the holder possesses or to which they have reasonable access.

• (3) The holder of the licence or authorization shall submit to the Minister the information that the Minister requests within the time limit specified in the request.

PART 2Custom-Made Devices and Medical Devices to Be Imported or Sold for Special Access

Application

• 69 (1) This Part applies to custom-made devices and medical devices that are to be imported or sold for special access.

• (2) In this Part, special access means access to a medical device for emergency use or if conventional therapies have failed, are unavailable or are unsuitable.

General

70 No person shall import or sell a Class III or IV custom-made device or a medical device for special access unless the Minister has issued an authorization for its sale or importation.

Authorization

• 71 (1) If a health care professional wishes to obtain a medical device referred to in section 70, the professional shall apply to the Minister for an authorization that would permit the manufacturer or importer of the device to sell, or to import and sell, the device to that professional.

• (2) The application shall contain the following:

  • (a) the name of the device, its class and 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;

  • (b) the number of units required;

  • (c) the name and address of the manufacturer or importer;

  • (d) the name, title and telephone number of the representative of the manufacturer or importer to contact for any information concerning the device;

  • (e) the diagnosis, treatment or prevention for which the device is required;

  • (f) a statement that sets out

    • (i) the reasons the device was chosen for the diagnosis, treatment or prevention,

    • (ii) the risks and benefits that are associated with its use, and

    • (iii) the reasons the diagnosis, treatment or prevention could not be accomplished using

      • (A) a licensed medical device that is available for sale in Canada, or

      • (B) a medical device for which the manufacturer of that device holds an authorization issued under section 68.12 and that is available for sale in Canada;

  • (g) the name and address of each health care facility at which the device is to be used by that professional;

  • (h) the known safety and effectiveness information in respect of the device;

  • (i) a written undertaking by the health care professional that the professional will inform the patient for whom the device is intended of the risks and benefits associated with its use;

  • (j) the directions for use, unless directions are not required for the device to be used safely and effectively; and

  • (k) in the case of a custom-made device, a copy of the health care professional’s written direction to the manufacturer giving the design characteristics of the device.

• 72 (1) The Minister shall issue an authorization referred to in subsection 71(1) to a manufacturer or importer if the Minister determines that

  • (a) the benefits that may be obtained by the patient through the use of the device outweigh the risks associated with its use;

  • (b) the health or safety of patients, users or other persons will not be unduly affected;

  • (c) a licensed device that would adequately meet the requirements of the patient is not available in Canada;

  • (c.1) a medical device for which the manufacturer of that device holds an authorization issued under section 68.12 and that would adequately meet the requirements of the patient is not available for sale in Canada; and

  • (d) the authorization is not being used by the manufacturer or importer to circumvent the requirements of Part 1 or 1.1.

• (2) The authorization issued under subsection (1) shall specify

  • (a) the number of units of the device authorized to be imported;

  • (b) the number of units of the device authorized to be sold; and

  • (c) the name of the health care professional to whom the manufacturer or importer may sell the device.

Additional Information

73 If the information and documents submitted in respect of an application made pursuant to section 71 are insufficient to enable the Minister to determine whether the conditions set out in subsection 72(1) have been met, the manufacturer, importer or health care professional shall, at the request of the Minister, submit any further information relevant to the application that the Minister may request.

74 The Minister may, in respect of an authorization that has been issued,

• (a) request the manufacturer, importer or health care professional to submit information in respect of the device if the Minister believes on reasonable grounds, after reviewing a report or information brought to the Minister’s attention, that the device for which the authorization has been issued no longer meets the conditions set out in subsection 72(1); and

• (b) issue a written cancellation of the authorization, giving reasons, if

  • (i) the Minister determines that the conditions set out in subsection 72(1) are no longer met, or

  • (ii) the information referred to in paragraph (a) has not been submitted.

Labelling

75 No person shall import or sell a medical device in respect of which an authorization has been issued pursuant to section 72, or a Class I or II custom-made device, unless the device has a label that

• (a) sets out the name of the manufacturer;

• (b) sets out the name of the device; and

• (c) specifies whether the device is a custom-made device or is being imported or sold for special access.

Distribution Records

76 The manufacturer or importer of a medical device in respect of which an authorization has been issued pursuant to section 72 shall maintain a distribution record in respect of the device in accordance with sections 52 to 56.

Incident Reporting

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.

Implant Registration

78 Sections 66 to 68 apply in respect of an implant that is imported or sold for special access.

PART 3Medical Devices for Investigational Testing Involving Human Subjects

Application

79 This Part applies to medical devices that are to be imported or sold for investigational testing involving human subjects.

General

• 80 (1) Subject to subsections (2) and (3), no person shall import or sell a medical device for investigational testing.

• (2) A manufacturer or importer of a Class II, III or IV medical device may sell the device to a qualified investigator for the purpose of conducting investigational testing if the manufacturer or importer holds an authorization issued under subsection 83(1) and possesses records that contain all the information and documents required by section 81.

• (3) A manufacturer or importer of a Class I medical device may sell the device to a qualified investigator for the purpose of conducting investigational testing if the manufacturer or importer possesses records that contain all the information and documents required by section 81.

Records

81 The records referred to in section 80 shall contain the following:

• (a) the name, address and telephone number of the manufacturer and the importer of the device;

• (b) the name of the device, its class and 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) a description of the device and of the materials used in its manufacture and packaging;

• (d) a description of the features of the device that permit it to be used for the medical conditions, purposes and uses for which it is manufactured, sold or represented;

• (e) a list of the countries other than Canada where the device has been sold, the total number of units sold in those countries, and a summary of any reported problems with the device and any recalls of the device in those countries;

• (f) a risk assessment comprising an analysis and evaluation of the risks, and the risk reduction measures adopted for the purposes of conducting investigational testing of the device, including, as appropriate,

  • (i) the results of any previous research, testing and studies conducted with respect to the device,

  • (ii) a description of the methods currently used to diagnose or treat the medical condition in respect of which the investigational testing is being proposed, and

  • (iii) information respecting any cautions, warnings, contra-indications and possible adverse effects associated with the use of the device;

• (g) the names of all the qualified investigators to whom the device is proposed to be sold and their qualifications, including their training and experience;

• (h) the name and address of each institution at which the investigational testing is proposed to be conducted and, in the case of a Class III or IV device, written approval from the institution indicating that the investigational testing may be carried out there;

• (i) a protocol of the proposed investigational testing, including the number of units of the device proposed to be used for the testing, the hypothesis for and objective of the testing, the period of time during which the testing will be carried out and a copy of the patient consent form;

• (j) a copy of the device label; and

• (k) a written undertaking from each qualified investigator to

  • (i) conduct the investigational testing in accordance with the protocol provided by the manufacturer,

  • (ii) inform a patient who is to be diagnosed or treated using the device of any risks and benefits associated with its use, and obtain the patient’s written consent for its use,

  • (iii) not use the device or permit it to be used for any purpose other than the investigational testing specified in the protocol,

  • (iv) not permit the device to be used by any other person except under the direction of the qualified investigator, and

  • (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.

Authorization

82 An application for an authorization referred to in subsection 80(2) shall be made in writing to the Minister and shall contain

• (a) in the case of a Class II medical device or a Class III or IV in vitro diagnostic device that is not used for patient management, not including a near-patient in vitro diagnostic device, the information set out in paragraphs 81(a), (b) and (h) to (j); and

• (b) in the case of a Class III or IV medical device that is not covered by paragraph (a), the information and documents set out in section 81.

• 83 (1) The Minister shall issue an authorization referred to in subsection 80(2) to a manufacturer or importer if the Minister determines that

  • (a) the device can be used for investigational testing without seriously endangering the life, health or safety of patients, users or other persons;

  • (b) the investigational testing is not contrary to the best interests of patients on whom the testing will be conducted; and

  • (c) the objective of the testing will be achieved.

• (2) The authorization referred to subsection (1) shall specify

  • (a) the name of any qualified investigator to whom the device may be sold;

  • (b) the type of diagnosis or treatment for which the device may be sold;

  • (c) the number of units of the device that are authorized to be sold; and

  • (d) the protocol according to which the investigational testing is to be conducted.

Additional Information

84 If the information and documents submitted in respect of an application made pursuant to section 82 are insufficient to enable the Minister to determine whether the conditions set out in subsection 83(1) have been met, the manufacturer or importer shall, at the request of the Minister, submit any further information relevant to the application that the Minister may request.

• 85 (1) The Minister may, in respect of a medical device in relation to which investigational testing is being conducted, request the manufacturer or importer of the device to submit information in respect of the testing if the Minister believes on reasonable grounds, after reviewing a report or information brought to the Minister’s attention, that one of the following conditions may exist:

  • (a) the testing seriously endangers the life, health or safety of patients, users or other persons;

  • (b) the testing is contrary to the best interests of patients on whom the testing is being conducted;

  • (c) the objective of the testing will not be achieved;

  • (d) the qualified investigator who is conducting the testing is not respecting the undertaking required by paragraph 81(k); or

  • (e) the information submitted in respect of the testing is false or misleading.

• (2) If the information requested pursuant to subsection (1) is not submitted, or if it is submitted and the Minister determines after reviewing it that a condition identified in that subsection exists, the Minister may, by written notice giving reasons,

  • (a) in the case of a Class I device, direct the manufacturer or importer of the device to stop selling the device to any qualified investigator named in the notice; or

  • (b) in the case of a Class II, III or IV device, cancel the authorization referred to in subsection 83(1), in whole or in part.