- active device
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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
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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
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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
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applicable requirements of sections 10 to 20 means
- bar code
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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
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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
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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
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custom-made device means a medical device, other than a mass-produced medical device, that
- directions for use
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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
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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
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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
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implant means a medical device that is listed in Schedule 2. (implant)
- invasive device
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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
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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
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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
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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
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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
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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
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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
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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
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recall means
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[...]
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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
[...]
- regulatory agency
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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
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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
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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
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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:
[...]
- surgical or dental instrument
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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
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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)