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  1. Medical Devices Regulations - SOR/98-282 (SCHEDULE 1 : Classification Rules for Medical Devices)
    Medical Devices Regulations

    [...]

    [...]

    Rule 1:

    • (1) Subject to subrules (2) and (3), all surgically invasive devices are classified as Class II.

    • (2) A surgically invasive device that is intended to diagnose, monitor, control or correct a defect of the central cardiovascular system or the central nervous system or of a fetus in utero is classified as Class IV.

    • (3) A surgically invasive device that is intended to be absorbed by the body, or that is normally intended to remain in the body for at least 30 consecutive days, is classified as Class III.

    Rule 2:

    • (1) Subject to subrules (2) to (4), all invasive devices that penetrate the body through a body orifice or that come into contact with the surface of the eye are classified as Class II.

    • (2) A device described in subrule (1) that is intended to be placed in the oral or nasal cavities as far as the pharynx or in the ear canal up to the ear drum is classified as Class I.

    • (3) A device described in subrule (1) that is normally intended to remain in the body or in contact with the surface of the eye for at least 30 consecutive days is classified as Class III.

    • (4) A device described in subrule (1) that is intended to be represented as preventing the transmission of infectious agents during sexual activities or reducing the risk thereof is classified as Class III.

    Rule 3:

    Despite rules 1 and 2

    • (a) all denture materials and orthodontic appliances, and their accessories, are classified as Class II;

    • (b) all surgical or dental instruments are classified as Class I; and

    • (c) all latex condoms are classified as Class II.

    [...]

    Rule 4:

    • (1) Subject to subrule (2), all non-invasive devices that are intended to come into contact with injured skin are classified as Class II.

    • (2) A device described in subrule (1) that is intended to be used as a mechanical barrier, for compression or for absorption of exudations, is classified as Class I.

    Rule 5:

    A non-invasive device intended for channelling or storing gases, liquids, tissues or body fluids for the purpose of introduction into the body by means of infusion or other means of administration is classified as Class II.

    Rule 6:

    • (1) Subject to subrules (2) and (3), a non-invasive device intended for modifying the biological or chemical composition of blood or other body fluids, or liquids, for the purpose of introduction into the body by means of infusion or other means of administration is classified as Class III.

    • (2) A device described in subrule (1) whose characteristics are such that the modification process may introduce a foreign substance into the body that is potentially hazardous, taking into account the nature and quantity of the substance, is classified as Class IV.

    • (3) A device described in subrule (1) that accomplishes the modification by centrifugation, gravity filtration or the exchange of gas or heat is classified as Class II.

    Rule 7:

    • (1) Subject to subrule (2), all other non-invasive devices are classified as Class I.

    • (2) A device described in subrule (1) is classified as Class II if it is intended

      • (a) to act as a calibrator, tester or quality control support to another medical device; or

      • (b) to be connected to an active device that is classified as Class II, III or IV.

    [...]

    Rule 8:

    • (1) Subject to subrules (2) and (3), an active device intended to emit ionizing radiation, including any device or software intended to control or monitor such a device or directly influence its performance, is classified as Class III.

    • (2) A device described in subrule (1) that is intended to be used in radiographic mode is classified as Class II.

    • (3) Despite subrule (2), an active device that is intended to be used for mammographies is classified as Class III.

    Rule 9:

    • (1) Subject to subrules (2) and (3), an active therapeutic device, including any dedicated software, intended to be used to administer or withdraw energy to or from the body is classified as Class II.

    • (2) If the administration or withdrawal by a device described in subrule (1) is potentially hazardous, taking into account the nature of the administration or withdrawal, the intensity of the energy and the part of the body concerned, the device is classified as Class III.

    • (3) A device described in subrule (2) that is intended to control the treatment of a patient’s condition through a closed loop system is classified as Class IV.

    Rule 10:

    • (1) Subject to subrule (2), an active diagnostic device, including any dedicated software, that supplies energy for the purpose of imaging or monitoring physiological processes is classified as Class II.

    • (2) A device described in subrule (1) that is intended to be used to monitor, assess or diagnose a disease, a disorder, an abnormal physical state or a pregnancy, if erroneous readings could result in immediate danger, is classified as Class III.

    Rule 11:

    • (1) Subject to subrules (2) and (3), an active device, including any dedicated software, intended to administer drugs, body fluids or other substances to the body or withdraw them from the body is classified as Class II.

    • (2) If the administration or withdrawal by a device described in subrule (1) is potentially hazardous, taking into account the nature of the administration or withdrawal, the nature of the substance involved and the part of the body concerned, the device is classified as Class III.

    • (3) A device described in subrule (2) that is intended to control the treatment of a patient’s condition through a closed loop system is classified as Class IV.

    Rule 12:

    Any other active device is classified as Class I.

    [...]

    Rule 13:

    A medical device that is intended to be used for

    • (a) disinfecting or sterilizing blood, tissues or organs that are intended for transfusion or transplantation is classified as Class IV; and

    • (b) disinfecting or sterilizing a medical device is classified as Class II.

    Rule 14:

    • (1) Subject to subrule (2), the following medical devices are classified as Class IV:

      [...]

    • (2) A device described in subrule (1) that is intended to come into contact with intact skin only is classified as Class I.

    [...]

    Rule 16:

    Despite rules 1 to 15, a medical device set out in column 1 of an item of the table to this rule is classified as the class set out in column 2 of that item.

    [...]

    Rule 1:

    An IVDD that is intended to be used to detect the presence of, or exposure to, a transmissible agent in blood, blood components, blood derivatives, tissues or organs to assess their suitability for transfusion or transplantation is classified as Class IV.

    Rule 2:

    An IVDD that is intended to be used to detect the presence of, or exposure to, a transmissible agent is classified as Class II, unless

    • (a) it is intended to be used to detect the presence of, or exposure to, a transmissible agent that causes a life-threatening disease if there is a risk of propagation in the Canadian population, in which case it is classified as Class IV; or

    • (b) it falls into one of the following categories, in which case it is classified as Class III:

      [...]

    Rule 3:

    An IVDD that is intended to be used for patient management is classified as Class II, unless it falls into one of the following categories, in which case it is classified as Class III:

    [...]

    Rule 4:

    An IVDD that is not subject to rules 1 to 3 and that is intended to be used in diagnosis or patient management is classified as Class II, unless it falls into one of the following categories, in which case it is classified as Class III:

    [...]

    Rule 5:

    An IVDD that is intended to be used for blood grouping or tissue typing to ensure the immunological compatibility of blood, blood components, tissue or organs that are intended for transfusion or transplantation is classified as Class III.

    [...]

    Rule 6:

    A near patient IVDD is classified as Class III.

    [...]

    Rule 8:

    If rules 1 to 7 do not apply, all other IVDDs are classified as Class I.

    Rule 9:

    Despite rules 1 to 8, an IVDD set out in column 1 of an item of the table to this rule is classified as the class set out in column 2 of that item.

    [...]


  2. Medical Devices Regulations - SOR/98-282 (Section 1)
    Medical Devices Regulations

    1 The definitions in this section apply in these Regulations.

    body orifice

    body orifice  means a natural opening or a permanent artificial opening in the body, such as a stoma. (orifice du corps)

    directions for use

    directions for use , in respect of a medical device, means full information as to the procedures recommended for achieving the optimum performance of the device, and includes cautions, warnings, contra-indications and possible adverse effects. (mode d’emploi)

    genetic testing

    genetic testing  means the analysis of DNA, RNA or chromosomes for purposes such as the prediction of disease or vertical transmission risks, or monitoring, diagnosis or prognosis. (test génétique)

    medical device group

    medical device group  means a medical device comprising a collection of medical devices, such as a procedure pack or tray, that is sold under a single name. (ensemble d’instruments)

    near patient in vitro diagnostic device

    near patient in vitro diagnostic device or near patient IVDD  means an in vitro diagnostic device that is intended for use outside a laboratory, for testing at home or at the point of care, such as a pharmacy, a health care professional’s office or the bedside. (instrument diagnostique clinique in vitro)

    objective evidence

    objective evidence  means information that can be proved true, based on facts obtained through observation, measurement, testing or other means, as set out in the definition objective evidence in section 2.19 of International Organization for Standardization standard ISO 8402:1994, Quality management and quality assurance - Vocabulary, as amended from time to time. (preuve tangible)

    qualified investigator

    qualified investigator  means a person who is a member in good standing of a professional association of persons entitled under the laws of a province to provide health care in the province and who is designated, by the ethics committee of the health care facility at which investigational testing is to be conducted, as the person to conduct the testing. (chercheur compétent)

    quality management system certificate

    quality management system certificate  means a valid quality management system certificate described in paragraph 32(2)(f), 3(j) or (4)(p), as applicable, that is issued by a registrar recognized by the Minister under section 32.1. (certificat de système de gestion de la qualité)

    validation

    validation  means confirmation by examination and the provision of objective evidence that the requirements for a specific intended use have been fulfilled, as set out in the definition validation in section 2.18 of International Organization for Standardization standard ISO 8402:1994, Quality management and quality assurance - Vocabulary, as amended from time to time. (validation)

    [...]


  3. Fees in Respect of Drugs and Medical Devices Regulations - SOR/2011-79 (Section 44)
    Fees in Respect of Drugs and Medical Devices Regulations
    Marginal note:Remission — anticipated gross revenue

    • 44 (1) Subject to subsection (4) and subsection 46(2), remission is granted of the amount by which the fee payable under section 39, 40 or 41, as applicable, exceeds 2.5% of the actual gross revenue from the medical device in question if that revenue is $100,000 or less and if

      • (a) the manufacturer provides with their licence application

        • (i) a statement signed by the individual responsible for the manufacturer’s financial affairs indicating that the anticipated gross revenue is $100,000 or less and certifying that the fee payable under section 39, 40 or 41, as applicable, is greater than an amount equal to 2.5% of that anticipated gross revenue,

        • (ii) information establishing that the fee payable under section 39, 40 or 41, as applicable, is greater than an amount equal to 2.5% of the anticipated gross revenue, and

      • (b) on the basis of the information provided under paragraph (a) and any other information available to the Minister, the Minister determines that the actual gross revenue will be $100,000 or less and that the fee payable under section 39, 40 or 41, as applicable, is likely to be greater than an amount equal to 2.5% of the actual gross revenue.

    • Marginal note:Amounts payable

      (2) The fee is then payable as follows:

      • (a) an amount equal to 2.5% of the anticipated gross revenue is payable in accordance with section 39 or 42, as applicable; and

      • (b) the amount, if any, by which the lesser of the fee referred to in section 39, 40 or 41, as applicable, and 2.5% of the actual gross revenue exceeds the amount paid under paragraph (a) is payable 60 days after the day on which the fee verification period ends.

    • [...]

    • Marginal note:Omission

      (4) If, within 60 days after the end of the fee verification period, the manufacturer has not provided the Minister with the sales records, the difference between the fee referred to in section 39, 40 or 41, as applicable, and the amount already paid is immediately payable.

    [...]


  4. Medical Devices Regulations - SOR/98-282 (Section 68.21)
    Medical Devices Regulations

    • 68.21 (1) The Minister may cancel an authorization for a medical device by written notice to the holder, giving reasons, if

      • [...]

      • (j) in the case of a Class III or IV device that is not a UPHN medical device,

        • (i) the holder does not, within 120 days after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of a contract, signed by both the holder and a registrar recognized by the Minister under section 32.1, that meets the following conditions:

          • (A) the contract indicates that the holder has begun the certification process to determine whether they have a quality management system that satisfies the standard referred to in paragraph 32(3)(j) or (4)(p), as the case may be, and

        • (ii) the holder does not, within two years after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of the quality management system certificate referred to in paragraph 32(3)(j) or (4)(p), as the case may be.

    • (1.1) If a medical device ceases to be a UPHN medical device after an application for an authorization is submitted under section 68.11 but before the Minister issues the authorization under section 68.12, the reference to “the device ceases to be a UPHN medical device” in subparagraph (1)(h)(i), (i)(i) or (j)(i), as the case may be, shall be read as “the Minister issued the authorization”.

    • (1.2) Subsection (1.1) ceases to apply in respect of the medical device if the device is authorized in relation to a medical condition that qualifies it as a UPHN medical device.

    • (2) A ground for cancellation specified in subparagraph (1)(i)(i) or (j)(i) does not apply if the holder has already provided the Minister with a copy of the quality management system certificate referred to in paragraph 32(2)(f), (3)(j) or (4)(p), as the case may be, or a copy of the contract referred to in the applicable subparagraph.

    • (3) A ground for cancellation specified in subparagraph (1)(i)(ii) or (j)(ii) does not apply if the holder has already provided the Minister with a copy of the quality management system certificate referred to in paragraph 32(2)(f), (3)(j) or (4)(p), as the case may be.

    [...]


  5. Fees in Respect of Drugs and Medical Devices Regulations - SOR/2011-79 (Section 28)
    Fees in Respect of Drugs and Medical Devices Regulations
    Marginal note:Activity

    • 28 (1) If an application to amend an establishment licence seeks to add an activity at a building, the fee for the examination of the application for each building at which the activity is to be added is,

      • [...]

      • (d) if the amendment seeks to authorize the holder to distribute drugs (other than drugs that are listed in Schedule C to the Food and Drugs Act and that are in dosage form) as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations but not to fabricate, package/label or import drugs, the basic fee set out in item 1, column 2, of Schedule 4; and

      • (e) if the amendment seeks to authorize the holder to distribute drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations, to distribute drugs that are listed in Schedule C to the Food and Drugs Act and that are in dosage form as a distributor referred to in paragraph C.01A.003(b) of those Regulations, to wholesale drugs or to conduct more than one of those activities, but not to fabricate, package/label or import drugs or to distribute drugs (other than drugs that are listed in Schedule C to that Act and that are in dosage form) as a distributor referred to in paragraph C.01A.003(b) of those Regulations, the basic fee set out in section 23.

    • (2) Subject to subsection (3), if an application to amend an establishment licence seeks to add a category in respect of an activity that is authorized by the licence at a building, the fee for the examination of the application for each building at which the category is to be added is,

      • [...]

      • (d) if the amendment seeks to authorize the holder to distribute a drug (other than a drug that is listed in Schedule C to the Food and Drugs Act and that is in dosage form) of an additional category as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations, the basic fee set out in item 1, column 2, of Schedule 4;

      • (e) if the amendment seeks to authorize the holder to distribute a drug of an additional category as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations, to distribute a drug that is listed in Schedule C to the Food and Drugs Act and that is in dosage form as a distributor referred to in paragraph C.01A.003(b) of those Regulations or to wholesale a drug of an additional category, the basic fee set out in section 23; and

    [...]


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