Medical Devices Regulations (SOR/98-282)

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.

Labelling

86 No person shall import or sell a medical device for investigational testing unless the device has a label that sets out

• (a) the name of the manufacturer;

• (b) the name of the device;

• (c) the statements “Investigational Device” and “Instrument de recherche”, or any other statement, in English and French, that conveys that meaning;

• (d) the statements “To Be Used by Qualified Investigators Only” and “Réservé uniquement à l’usage de chercheurs compétents”, or any other statement, in English and French, that conveys that meaning; and

• (e) in the case of an IVDD, the statements “The performance specifications of this device have not been established” and “Les spécifications de rendement de l’instrument n’ont pas été établies”, or any other statement, in English and French, that conveys that meaning.

Advertising

87 No person shall advertise a medical device that is the subject of investigational testing unless

• (a) that person holds an authorization issued under subsection 83(1) to sell or import the device; and

• (b) the advertisement clearly indicates that the device is the subject of investigational testing, and the purpose of the investigational testing.

Other Requirements

88 The requirements set out in the following provisions apply to medical devices to which this Part applies:

• (a) sections 52 to 56 with respect to distribution records;

• (b) sections 57 and 58 with respect to complaint handling;

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

• (d) sections 63 to 65.1 with respect to recalls; and

• (e) sections 66 to 68 with respect to implant registration.

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).

PART 4Export Certificates

• 89 (1) For the purposes of section 37 of the Act, Schedule 3 sets out the form to be used for an export certificate for medical devices.

• (2) The export certificate shall be signed and dated by

  • (a) where the exporter of the device is a corporation,

    • (i) the exporter’s senior executive officer in Canada,

    • (ii) the exporter’s senior regulatory officer in Canada, or

    • (iii) the authorized agent of the person referred to in subparagraph (i) or (ii); or

  • (b) where the exporter of the device is an individual,

    • (i) the exporter, or

    • (ii) the exporter’s authorized agent.

90 No person shall sign an export certificate that is false or misleading or that contains omissions that may affect its accuracy and completeness.

91 The exporter of a device shall maintain, at their principal place of business in Canada, records that contain the completed export certificates and shall, when requested to do so by an inspector, submit the export certificates for examination.

92 The exporter of a device shall retain the export certificate for a period of not less than five years after the date of export.

PART 5Transitional Provisions, Repeal and Coming into Force

Transitional Provisions

93 For the purposes of sections 94 and 95, old regulations means the Medical Devices Regulations, C.R.C., c. 871, and Director has the meaning assigned to it by those regulations.

• 94 (1) Subject to subsection (2), if an application for a notice of compliance has been submitted with respect to a medical device pursuant to Part V of the old regulations but has not been processed by the Director as of June 30, 1998, an application for a medical device licence shall be made pursuant to these Regulations.

• (2) For the purposes of an application for a medical device licence, the information and documents required by paragraphs 32(2)(a) to (e), (3)(a) to (i) or (4)(a) to (o) are deemed to have been submitted if a notice of compliance with respect to the device had been issued under the old regulations.

• 95 (1) A medical device that, on June 30, 1998, is being sold in Canada pursuant to the old regulations is not required to be licensed until February 1, 1999, if,

  • (a) in the case of a device that is subject to Part V of the old regulations, the manufacturer

    • (i) has a notice of compliance in respect of the device that is in effect on June 30, 1998, or

    • (ii) does not have a notice of compliance in respect of the device that is in effect on June 30, 1998, but has met, during the period beginning on October 8, 1982, and ending on March 31, 1983, the requirements for device notification pursuant to Part II of the old regulations in respect of the device; and

  • (b) in the case of a device that is not subject to Part V of the old regulations, the manufacturer has, by June 30, 1998, furnished the Director with the notification required in subsection 24(1) of the old regulations in respect of the device.

• (2) If an initial application for licensing of a medical device that is referred to in subsection (1) is submitted before February 1, 1999, the information and documents required by paragraphs 32(2)(a) to (e), (3)(a) to (i) or (4)(a) to (o) are deemed to have been submitted if

  • (a) in the case of a device that is subject to Part V of the old regulations, the manufacturer

    • (i) has a notice of compliance in respect of the device that is in effect on June 30, 1998, or

    • (ii) does not have a notice of compliance that is in effect on June 30, 1998, in respect of the device, but has met, during the period beginning on October 8, 1982, and ending on March 31, 1983, the requirements for device notification pursuant to Part II of the old regulations in respect of the device;

  • (b) in the case of a device that is not subject to Part V of the old regulations, the manufacturer has, by June 30, 1998, furnished the Director with the notification required in subsection 24(1) of the old regulations in respect of the device.

• (3) Subsections (1) and (2) cease to apply in respect of a medical device if a change described in section 34 is made in respect of the device or if the notice of compliance is suspended or cancelled under section 40 of the old regulations.

• (4) For the purposes of this section, a notice of compliance may be suspended or cancelled under section 40 of the old regulations as if that section were still in force.