The Medical Devices Introductory Course 2020

Regulatory Framework

Food & Drug Act (R.S.C., 1985, c.F27) as last amended 2014-Nov-06, covers food, cosmetics, drugs, devices and transplantation, and annexes the following regulations: •Food & Drugs Regulations (FDR) (C.R.C., c. 870) as last amended 2015-Jul-16 covers food, drugs and cosmetics •Medical Devices Regulations (MDR) (SOR / 98-282) as last amended 2011-Dec-16 covers medical devices and in-vitro devices •Safety of Human Cells, Tissues and Organs for Transplantation Regulations (SOR / 2007-118) as last amended 2015-Feb-11 covers human derived transplants The Food & Drug Act includes definitions for drugs and devices (see following slides) but does not include a definition for “Combination Products”. It does, however, define “Therapeutic Products” (and mentions “combinations” of drugs and devices), as follows: “ Therapeutic Product means a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Product Regulations ”

What is a Medical Device? Definition Food and Drugs Act [ R.S.C., 1985, c. F-27; Interpretation / Definitions, Section 2]:

“device” means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in ( a ) diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals, ( b ) restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals, ( c ) diagnosing pregnancy in human beings or animals, ( d ) caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or ( e ) preventing conception in human beings or animals; however, it does not include such an instrument, apparatus, contrivance or article, or a component, part or accessory of any of them, that does any of the actions referred to in paragraphs ( a ) to ( e ) solely by pharmacological, immunological or metabolic means or solely by chemical means in or on the body of a human being or animal;

The Organisation for Professionals in Regulatory Affairs