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Food and Drugs Act (FDA)

Overview​

The Food and Drugs Act (RSC 1985, c F-27) is Canada's primary legislation governing foods, drugs, cosmetics, and medical devices. It is the enabling statute that gives Health Canada the authority to regulate medical devices and to make subordinate regulations.

The FDA does not contain detailed device-specific requirements — those are in the Medical Devices Regulations (SOR/98-282). The FDA provides the foundational framework:

  • The definition of "device" (s 2)
  • The prohibition on selling unsafe or mislabelled devices (ss 20, 21)
  • The advertising offence provisions (ss 9, 20)
  • The recall and seizure authorities (ss 21.3, 23)
  • The offence and penalty provisions (ss 31–32)
  • The regulation-making powers delegated to the Governor in Council (s 30)

Key provisions for medical devices​

Section 2 — Definitions​

Defines "device" (the definition that scopes what is regulated), "manufacturer", "importer", "distributor", and other key terms.

Section 20 — Prohibition on sale of unsafe devices​

Prohibits the sale of a device that:

  • May cause injury to health when used as directed
  • Has a label that is false or misleading
  • Is manufactured, prepared, preserved, packaged, or stored under unsanitary conditions

Section 21 — Sale without a licence​

Makes it an offence to sell a Class II, III, or IV device in Canada without a valid Device Licence.

Section 21.3 — Recall orders​

Authorises the Minister to order a mandatory recall if a device presents a serious risk of injury to health.

Section 23 — Seizure and detention​

Authorises Health Canada inspectors to seize devices that may be non-compliant or unsafe.

Section 30 — Regulation-making powers​

Authorises the Governor in Council to make regulations governing medical devices. This is the authority under which the Medical Devices Regulations (SOR/98-282) were made.

How the FDA relates to the MDR​

The Food and Drugs Act is the parent statute. The Medical Devices Regulations are subordinate legislation made under the FDA. All MDR requirements must be consistent with the FDA framework.

Official source

Food and Drugs Act — laws-lois.justice.gc.ca