Anwendungsbereich des Regulatory Essentials
Geltende Rechtsvorschriften:
This law regulates: Foods, Drugs, Cosmetics and (Medical) 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;
Articles 19, 20, 21 refer to (Medical) Devices.
Article 31 refers to Offences and Punishment
Abbreviation of the Canadian Medical Device Regulation: CMDR
Art. 2 - Application
These Regulations apply to
(a) the sale and advertising for sale of a medical device; and
(b) the importation of a medical device for sale or for use on individuals, other than importation for personal use.
Art.10 - 20 Safety and Effectiveness Requirements
Art.21 - 23 Labelling Requirements
Art.25 - Class I Medical Devices
Art.26 - 32 Class II, III and IV Medical Devices