Medical Devices Regulations

Vol. 132, No. 11 — May 27, 1998

Registration SOR/98-282 7 May, 1998

FOOD AND DRUGS ACT

Medical Devices Regulations

P.C. 1998-783 7 May, 1998

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) of the Food and Drugs Act, hereby makes the annexed Medical Devices Regulations.

TABLE OF CONTENTS

(This table is not part of the Regulations.)

MEDICAL DEVICES REGULATIONS

SectionINTERPRETATION 1APPLICATION 2CLASSIFICATION OF MEDICAL DEVICES 6PART 1 - GENERAL  Application 8Manufacturer's Obligations 9Safety and Effectiveness Requirements 10Labelling Requirements 21Contraceptive Devices — Advertising 24Class I Medical Devices 25Class II, III and IV Medical Devices  Prohibition 26Medical Devices Deemed Licensed 28Application for a Medical Device Licence 32Foreign Manufacturers 33Application for a Medical Device Licence Amendment 34Additional Information and Samples 35Issuance 36Lot of In Vitro Diagnostic Devices 37Refusal to Issue 38Additional Information 39Suspension 40Obligation to Inform 43Establishment Licence  Prohibition 44Application 45Issuance 46Refusal 47Notification 48Suspension 49Distribution Records 52Complaint Handling 57Mandatory Problem Reporting 59Recall 63Implant Registration 66PART 2 - CUSTOM-MADE DEVICES AND MEDICAL DEVICES TO BE IMPORTED OR SOLD FOR SPECIAL ACCESS  Application 69General 70Authorization 71Additional Information 73Labelling 75Distribution Records 76Reporting an Incident 77Implant Registration 78PART 3 - MEDICAL DEVICES FOR INVESTIGATIONAL TESTING INVOLVING HUMAN SUBJECTS  Application 79General 80Records 81Authorization 82Additional Information 84Labelling 86Advertising 87Other Requirements 88PART 4 - EXPORT CERTIFICATES 89PART 5 - TRANSITIONAL PROVISIONS, REPEAL AND COMING INTO FORCE  Transitional Provisions 93Repeal 96Coming into Force 97SCHEDULE 1 - CLASSIFICATION RULES FOR MEDICAL DEVICES  SCHEDULE 2 - IMPLANTS  SCHEDULE 3 - EXPORT CERTIFICATE FOR MEDICAL DEVICES        MEDICAL DEVICES REGULATIONS

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)

"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...

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