Medical Devices Regulations (SOR/98-282)

Regulations are current to 2014-10-27 and last amended on 2011-12-16. Previous Versions

Medical Devices Regulations

SOR/98-282

FOOD AND DRUGS ACT

Registration 1998-05-07

Medical Devices Regulations

P.C. 1998-783 1998-05-07

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsections 3(3), 30(1) and 37(1)Footnote a of the Food and Drugs Act, hereby makes the annexed Medical Devices Regulations.

INTERPRETATION

 The definitions in this section apply in these Regulations.

“Act”

“Act” means the Food and Drugs Act. (Loi)

“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)

“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)

“body orifice”

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

“central cardiovascular system”

“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”

“central nervous system” means the brain, meninges, spinal cord and cerebrospinal fluid. (système nerveux central)

“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)

“Commissioner of Patents”

“Commissioner of Patents” means the Commissioner of Patents appointed under subsection 4(1) of the Patent Act. (commissaire aux brevets)

“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

  • (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)

“dental material”

“dental material”[Repealed, SOR/2002-190, s. 1]

“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)

“General Council Decision”

“General Council Decision” has the meaning assigned by subsection 30(6) of the Act. (décision du Conseil général)

“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)

“health care facility”

“health care facility” means a facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities. (établissement de santé)

“health care professional”

“health care professional” means a person who is entitled under the laws of a province to provide health services in the province. (professionnel de la santé)

“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 vitroouIDIV)

“manufacturer”

“manufacturer” means a person who sells a medical device under their own name, or under a trade-mark, 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)

“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)

“person”

“person” includes a partnership and an association. (personne)

“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)

“quality system certificate”

“quality system certificate”[Repealed, SOR/2006-197, s. 1]

“recall”

“recall”, in respect of a medical device that has been sold, means any action taken by the manufacturer, importer or distributor of the device 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

  • (a) may be hazardous to health;

  • (b) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety; or

  • (c) may not meet the requirements of the Act or these Regulations. (rappel)

“safety and effectiveness requirements”

“safety and effectiveness requirements” means the safety and effectiveness requirements set out in sections 10 to 20. (exigences en matière de sûreté et d’efficacité)

“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)

“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:

  • (a) the manufacturing process, facility or equipment;

  • (b) the manufacturing quality control procedures, including the methods, tests or procedures used to control the quality, purity and sterility of the device or of the materials used in its manufacture;

  • (c) the design of the device, including its performance characteristics, principles of operation and specifications of materials, energy source, software or accessories; and

  • (d) the intended use of the device, including any new or extended use, any addition or deletion of a contra-indication for the device and any change to the period used to establish its expiry date. (modification importante)

“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)

“surgically invasive device”

“surgically invasive device” means an invasive device that is intended to enter the body through an artificially created opening that provides access to body structures and fluids. (instrument effractif chirurgical)

“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)

“test kit”

“test kit” means an in vitro diagnostic device that consists of reagents or articles, or any combination of these, and that is intended to be used to conduct a specific test. (trousse d’essai)

“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)

  • SOR/2002-190, s. 1;
  • SOR/2003-173, s. 1;
  • SOR/2005-142, s. 1;
  • SOR/2006-197, s. 1.