Anwendungsbereich des Regulatory Essentials
Geltende Rechtsvorschriften:
This law regulates: Foods, Drugs, Cosmetics and Devices.
Definition of "DEVICE":
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;
Definition of "Therapeutic Product"
- a drug or device or any combination of drugs and devices
Articles 19 - 21 refer to Devices.
Article 21.1 - 21.8 refer to Therapeutic Products
Article 31 refers to Offences and Punishment
Abbreviation of the Canadian Medical Device Regulation: CMDR
Definition of "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.
Section 3 (1) - These regulations apply to an in vitro diagnostic product that is a drug or that contains a drug as if the product were a medical device.
SCHEDULE 1 - Classification Rules for Medical Devices
Part 2 - In Vitro Diagnostic Devices (9 rules listed)