Scope: |
This ESSENTIAL describes the regulatory requirements of medical devices in Canada, based on
- Food and Drugs Act
- Canadian Medical Devices Regulations (SOR/98-282) - abbreviated: CMDR
- Health Canada Guidance Documents
Health products in Canada are classified into four risk classes, according to the risk classification:
Class I - low risk
Class II - medium risk
Class III - high risk
Class IV - highest risk
Health Canada issues two different types of licences for medical devices:
1.) Medical Device Licence (MDL) – a licence issued to manufacturers authorizing them to import or sell their Class II, III or IV medical devices in Canada.
2.) Medical Device Establishment Licence (MDEL) – a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada.
Not in scope of this CRF (although also regulated by the Food and Drugs Act and CMDR)
- In-Vitro Diagnostics (see: ESSENTIAL CAN In-Vitro Diagnostics)
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Legislation in force: |
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 and 20 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
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