Glossary of Key Terms
This glossary defines key terms as used in Canadian medical device regulation. Where a term has a specific meaning under the Food and Drugs Act or Medical Devices Regulations, the legislative source is noted.
Class I / II / III / IV The four risk-based classes into which medical devices are classified under Schedule 2 of the Medical Devices Regulations. Class I = lowest risk; Class IV = highest risk. Class determines licensing requirements and the level of pre-market evidence required.
Custom-made device A device manufactured to meet the specific needs of a named patient, on the written instructions of a healthcare professional, and not manufactured in series. Custom-made devices are exempt from Device Licence requirements but remain subject to other obligations.
Device Licence The market authorisation issued by Health Canada to manufacturers of Class II, III, and IV medical devices. The Device Licence number must be referenced on labelling (for some classes) and in correspondence with Health Canada. Equivalent to the ARTG listing (Australia) or CE mark (EU).
Distributor A person who distributes medical devices at the wholesale level after manufacture and importation. Must hold an MDEL.
Establishment Licence → see MDEL
FDA Food and Drugs Act (RSC 1985, c F-27) — the primary Canadian legislation governing therapeutic products, including medical devices. Not to be confused with the US FDA (Food and Drug Administration).
Field Safety Corrective Action (FSCA) An action taken by a manufacturer to reduce a risk of death or serious deterioration in health associated with a device already placed on the market. Includes recalls, modifications, replacements, and safety notices.
Field Safety Notice (FSN) A communication from a manufacturer to customers and users describing an FSCA and the required customer action.
ITA Investigational Testing Authorization — Health Canada authorisation required to use an unlicensed device in a clinical investigation in Canada. See ITA.
Importer A person who brings medical devices into Canada for the purpose of sale. Must hold an MDEL.
MDALL Medical Devices Active Licence Listing — Health Canada's publicly searchable database of devices holding a current Device Licence in Canada. Available at canada.ca.
MDEL Medical Device Establishment Licence — the licence required by importers, wholesale distributors, and Class I manufacturers. See Establishment Licence (MDEL).
MDD Medical Devices Directorate — the Health Canada directorate within the Health Products and Food Branch responsible for regulating medical devices.
MDR Medical Devices Regulations (SOR/98-282) — the principal regulations governing medical devices in Canada.
MDSAP Medical Device Single Audit Program — an international audit program whose certificate is required for Device Licence applications to Health Canada. Participating jurisdictions: Canada, USA, Australia, Brazil, Japan. See MDSAP in Depth.
MedEffect Health Canada's online portal for reporting adverse reactions and medical device incidents. Available at canada.ca/medeffect.
Mandatory Problem Report (MPR) A report that manufacturers, importers, and distributors are required to submit to Health Canada when a reportable incident involving a medical device occurs.
Manufacturer A person who sells a medical device under their own name or assigns a name or mark to a device, and who designs, fabricates, produces, packages, processes, or labels the device.
REDA Radiation Emitting Devices Act (RSC 1985, c R-1) — legislation governing devices that emit radiation, which applies in addition to (or instead of) the Medical Devices Regulations for some device types.
SAP Special Access Program — Health Canada program that allows access to unlicensed medical devices for specific patients in exceptional circumstances. See Special Access Program.
Safety and Effectiveness Requirements The requirements set out in Schedule 1 of the MDR that all licensed devices must meet. Equivalent to Essential Principles (Australia) or GSPR Annex I (EU).
SaMD Software as a Medical Device — software that qualifies as a medical device in its own right, not embedded software that drives a hardware medical device. See Software as a Medical Device.
Single-use device A device intended to be used on a single patient during a single procedure and then discarded. Single-use designation must be clearly labelled. See Single-Use Devices.
UDI Unique Device Identification — a system for identifying medical devices through their distribution and use. Health Canada is developing a UDI framework aligned with international standards. See UDI Framework.