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Marginal note:Content of label

• 45 (1) Subject to subsection (4), the label referred to in subsections 44(1) and (2) must contain

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  • (f) directions for use, including details to permit the safe and effective use of the feed for its intended purpose by users with no specialized knowledge of the purpose and use of the feed, and

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    • (ii) in the case of a custom medicated feed, the prescribed period of medication, as indicated on the veterinary prescription;

• (2) The label referred to in subsections 44(1) and (2) must also contain

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  • (c) in the case of a medicated feed, other than a custom medicated feed, the following information as set out in the Compendium of Medicating Ingredient Brochures for each medicating ingredient present in the feed:

    • (i) the name and actual amount of the medicating ingredient, immediately after the feed name,

    • (ii) the approved claim for the species of livestock for which the feed is intended, when the medicating ingredient is used at the level indicated in the Compendium for that claim,

    • (iii) any warning statement applicable to the medicating ingredient and, in the case of a feed that contains more than one medicating ingredient with a warning statement that contains a withdrawal time, the warning statement containing the longest withdrawal time, immediately after the headings “Warning” and “Mise en garde” and clearly separated from other information shown on the label,

    • (iv) any caution statement applicable to the medicating ingredient, immediately after the headings “Caution” and “Précaution” and clearly separated from other information shown on the label,

    • (v) any statement on the prudent use of the medicating ingredient,

  • (d) in the case of a custom medicated feed,

    • [...]

    • (iii) immediately after the feed name, the name and actual amount of each medicating ingredient present in the feed, and

    • (iv) any applicable caution statement or warning statement indicated on the veterinary prescription in respect of each medicating ingredient present in the feed, immediately after the headings “Warning” and “Mise en garde” or “Caution” and “Précaution”, as the case may be, and clearly separated from other information shown on the label.

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• (4) In the case of a customer formula feed, the label referred to in subsections 44(1) and (2) must contain

  • (a) if the feed does not contain a medicating ingredient,

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  • (b) if it contains a medicating ingredient,

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1 The definitions in this section apply in these Regulations.

active device

active device  means a medical device that depends for its operation on a source of energy other than energy generated by the human body or gravity. A medical device that transmits or withdraws energy or a substance to or from a patient without substantially altering the energy or the substance is not an active device. (instrument actif)

active diagnostic device

active diagnostic device  means an active device that, whether used alone or in combination with another medical device, is intended to supply information for the purpose of detecting, monitoring or treating a physiological condition, state of health, illness or congenital deformity. (instrument diagnostique actif)

active therapeutic device

active therapeutic device  means an active device that, whether used alone or in combination with another medical device, is intended to support, modify, replace or restore a biological function or structure for the purpose of treating or mitigating an illness or injury or a symptom of an illness or injury. (instrument thérapeutique actif)

applicable requirements of sections 10 to 20

applicable requirements of sections 10 to 20  means

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• (b) in respect of any other medical device, the requirements set out in section 10, subsections 11(1) and 12(1) and sections 13 to 20. (exigences applicables prévues aux articles 10 à 20)

bar code

bar code  means a unique bar code in the symbology of the Universal Product Code (UPC), the Health Industry Business Communications Council (HIBCC) or the European Article Number (EAN), assigned to a medical device by the manufacturer. (code à barres)

closed-loop system

closed-loop system , in respect of a medical device, means a system that enables the device to sense, interpret and treat a medical condition without human intervention. (système à boucle fermée)

control number

control number  means a unique series of letters, numbers or symbols, or any combination of these, that is assigned to a medical device by the manufacturer and from which a history of the manufacture, packaging, labelling and distribution of a unit, lot or batch of the device can be determined. (numéro de contrôle)

custom-made device

custom-made device  means a medical device, other than a mass-produced medical device, that

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• (b) differs from medical devices generally available for sale or from a dispenser; and

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)

dispenser

dispenser  means a person who is a member of a professional governing body and who is entitled, by virtue of their membership in that body, to manufacture or adapt a medical device in accordance with a health care professional’s written directions in order to meet the specific requirements of a patient. (préparateur)

identifier

identifier  means a unique series of letters or numbers or any combination of these or a bar code that is assigned to a medical device by the manufacturer and that identifies it and distinguishes it from similar devices. (identificateur)

implant

implant  means a medical device that is listed in Schedule 2. (implant)

invasive device

invasive device  means a medical device that is intended to come into contact with the surface of the eye or penetrate the body, either through a body orifice or through the body surface. (instrument effractif)

in vitro diagnostic device

in vitro diagnostic device or IVDD  means a medical device that is intended to be used in vitro for the examination of specimens taken from the body. (instrument diagnostique in vitro ou IDIV)

manufacturer

manufacturer  means a person who sells a medical device under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf. (fabricant)

medical device

medical device  means a device within the meaning of the Act, but does not include any device that is intended for use in relation to animals. (instrument médical)

medical device family

medical device family  means a group of medical devices that are made by the same manufacturer, that differ only in shape, colour, flavour or size, that have the same design and manufacturing process and that have the same intended use. (famille d’instruments)

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)

medical device group family

medical device group family  means a collection of medical device groups that are made by the same manufacturer, that have the same generic name specifying their intended use, and that differ only in the number and combination of products that comprise each group. (famille d’ensembles d’instruments)

name of the device

name of the device , in respect of a medical device, includes any information necessary for the user to identify the device and to distinguish it from similar devices. (nom de l’instrument)

recall

recall  means

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• (b) any action taken by a manufacturer, importer or distributor of a medical device, after the device has been sold, to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device

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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)

serious deterioration in the state of health

serious deterioration in the state of health  means a life-threatening disease, disorder or abnormal physical state, the permanent impairment of a body function or permanent damage to a body structure, or a condition that necessitates an unexpected medical or surgical intervention to prevent such a disease, disorder or abnormal physical state or permanent impairment or damage. (détérioration grave de l’état de santé)

shortage

shortage , in respect of a medical device, means a situation in which the manufacturer of the device is unable to meet the demand for the device in Canada. (pénurie)

significant change

significant change  means a change that could reasonably be expected to affect the safety or effectiveness of a medical device. It includes a change to any of the following:

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surgical or dental instrument

surgical or dental instrument  means a reusable medical device that is intended for surgical or dental use, including cutting, drilling, sawing, scraping, clamping, hammering, puncturing, dilating, retracting or clipping, without connection to an active device. (instrument chirurgical ou dentaire)

system

system  means a medical device comprising a number of components or parts intended to be used together to fulfil some or all of the device’s intended functions, and that is sold under a single name. (système)

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

  • (a) the Minister has reasonable grounds to believe that the holder has contravened these Regulations or any provision of the Act relating to medical devices;

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  • (h) in the case of a Class I 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, submit an application under section 45 for an establishment licence that would authorize the holder to sell or import the device,

  • (i) in the case of a Class II 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:

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    • (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(2)(f); or

  • (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:

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    • (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.

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68.01 The following definitions apply in this Part.

COVID-19 medical device

COVID-19 medical device [Repealed, SOR/2023-277, s. 3]

List of Medical Devices for an Urgent Public Health Need

List of Medical Devices for an Urgent Public Health Need  means the List of Medical Devices for an Urgent Public Health Need that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux pour des besoins urgents en matière de santé publique)

List of Medical Devices for Expanded Use

List of Medical Devices for Expanded Use  means the List of Medical Devices for Expanded Use that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux destinés à un usage élargi)

UPHN medical device

UPHN medical device  means any of the following medical devices for an urgent public health need:

• (a) a medical device that is set out in column 2 of Part 1 of the List of Medical Devices for an Urgent Public Health Need and that is manufactured, sold or represented for use in relation to the corresponding medical condition that is set out in column 1;

• (b) a medical device that belongs to a category of medical devices that is set out in column 2 of Part 2 of that list and that is manufactured, sold or represented for use in relation to the corresponding medical condition that is set out in column 1. (instrument médical BUSP)

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• 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:

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  • (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;

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  • (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.

  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)

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