What is a Medical Device?
Regulatory definition
Under the Food and Drugs Act (FDA), a medical device is defined as any article, instrument, apparatus, or contrivance — including any component, part, or accessory — manufactured, sold, or represented for use in:
- the diagnosis, treatment, mitigation, or prevention of a disease, disorder, or abnormal physical state, or its symptoms, in human beings or animals
- restoring, correcting, or modifying a body function or the body structure of human beings or animals
- the diagnosis of pregnancy in human beings or animals
- the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring
A medical device does not achieve its primary intended action by chemical, pharmacological, immunological, or metabolic means — this is the principal distinction from a drug.
Legislative source: Food and Drugs Act, RSC 1985, c F-27, s 2 (definition of "device")
Examples of medical devices
| Category | Examples |
|---|---|
| Diagnostic equipment | X-ray machines, MRI scanners, ultrasound devices, ECG monitors |
| Implants | Hip and knee replacements, pacemakers, cochlear implants, breast implants |
| Surgical instruments | Scalpels, forceps, endoscopes, surgical robots |
| In vitro diagnostics | Blood glucose meters, pregnancy tests, COVID-19 rapid antigen tests |
| Monitoring devices | Blood pressure monitors, pulse oximeters, continuous glucose monitors |
| Wound care | Dressings, bandages, sutures, wound closure strips |
| Software | Clinical decision support software, diagnostic AI algorithms, SaMD |
| Dental devices | Dental implants, orthodontic appliances, dental drills |
| Ophthalmic | Contact lenses, intraocular lenses, tonometers |
Intended use is decisive
Classification and regulatory requirements depend significantly on a device's intended use — what the manufacturer claims the device is for. Relevant factors include:
- The medical condition it is intended to diagnose, treat, or prevent
- The intended patient population
- The anatomical location of use
- Whether use is by a healthcare professional or a lay person
- Whether use is single-use or multi-use
Manufacturers cannot escape regulation by omitting medical claims from labelling if the device is clearly intended for a medical purpose based on its design or marketed context.
Combination products
Some products combine a drug component and a device component — for example, a drug-eluting stent, a pre-filled syringe, or a transdermal drug delivery patch. Health Canada determines which regulatory pathway applies based on the primary mode of action. See Combination Products (Drug-Device) for more detail.
Software
Software that meets the definition of a medical device — by performing a medical purpose through its own output — is regulated as a medical device. See Software as a Medical Device (SaMD) for Health Canada's approach.
Animals
The definition includes devices for use in animals, not only humans. Veterinary devices are regulated under the same framework.