文档介绍：Medical Devices Regulations
SOR/98-282
Registration 7 May, 1998
FOOD AND DRUGS ACT
Medical Devices Regulations
. 1998-783 7 May, 1998
His Excellency the Governor General in Council, on the mendation of the Minister of Health, pursuant to subsections 3(3), 30(1) and 37(1)a of the Food and Drugs Act, hereby makes the annexed Medical Devices Regulations.
a . 1993, c. 34, s. 73
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 bination 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 bination 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 munications Council () 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, card