- INTERPRETATION
- APPLICATION
- CLASSIFICATION OF MEDICAL DEVICES
- PART 1
- GENERAL
- Application
- Manufacturer’s Obligations
- Safety and Effectiveness Requirements
- Labelling Requirements
- Contraceptive Devices — Advertising
- Class I Medical Devices
- Class II, III and IV Medical Devices
- Prohibition
- Medical Devices Deemed Licensed
- Application for a Medical Device Licence
- Quality Management System Certificate
- Foreign Manufacturers
- Application for a Medical Device Licence Amendment
- Additional Information and Samples
- Issuance
- Lot of In Vitro Diagnostic Devices
- Refusal to Issue
- Additional Information
- Suspension
- Obligation to Inform
- Obligation to Submit Certificate
- Medical Devices to Be Sold for the Purposes of Implementing the General Council Decision
- GENERAL
- PART 2
- PART 3
- PART 4
- PART 5
- SCHEDULE 1
- SCHEDULE 2
- SCHEDULE 3
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)aof the Food and Drugs Act, hereby makes the annexed Medical Devices Regulations.
aS.C. 1993, c. 34, s. 73
INTERPRETATION
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)
“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)
“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)
“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)
“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” has the meaning assigned by subsection 30(6) of the Act. (décision du Conseil général)
“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” 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” means a person who is entitled under the laws of a province to provide health services in the province. (professionnel de la santé)
“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” means a medical device that is listed in Schedule 2. (implant)
“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” 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” 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” 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” 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” 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” 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”, 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” 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” 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” includes a partnership and an association. (personne)
“qualified investigator” means a person who is a member in good standing of a professional