Medical Devices Regulations — 1
1 The definitions in this section apply in these Regulations. Act means the Food and Drugs Act . ( Loi ) 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 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 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 means (a) in respect of a decorative contact lens, the requirements set out in section 10, subsections 11(2) and 12(2) and sections 13 to 17; and (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 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 ) body orifice means a natural opening or a permanent artificial opening in the body, such as a stoma. ( orifice du corps ) business day means a day other than (a) a Saturday; or (b) a Sunday or other holiday. ( jour ouvrable ) central cardiovascular system means the heart, pericardium, pulmonary veins, pulmonary arteries, cardiac veins, coronary arteries, common carotid arteries, cerebral arteries, brachiocephalic artery, aorta, inferior and superior vena cava, renal arteries, iliac arteries and femoral arteries. ( système cardiovasculaire central ) central nervous system means the brain, meninges, spinal cord and cerebrospinal fluid. ( système nerveux central ) 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 ) Commissioner of Patents means the Commissioner of Patents appointed under subsection 4(1) of the Patent Act. ( commissaire aux brevets ) 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 means a medical device, other than a mass-produced medical device, that (a) is manufactured in accordance with a health care professional’s written direction giving its design characteristics; (b) differs from medical devices generally available for sale or from a dispenser; and (c) is (i) for the sole use of a particular patient of that professional, or (ii) for use by that professional to meet special needs arising in the course of his or her practice. ( instrument fait sur mesure ) decorative contact lens means a device referred to in section 2.1 of the Act. ( lentilles cornéennes à but esthétique ) dental material [Repealed, SOR/2002-190, s. 1] 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