How to Read Canadian Legislation
Where to find Canadian legislation
All federal legislation is available free of charge at laws-lois.justice.gc.ca. This is the authoritative online source for:
- Acts (statutes passed by Parliament) — e.g., Food and Drugs Act
- Regulations (subordinate legislation made under Acts) — e.g., Medical Devices Regulations (SOR/98-282)
All texts are available in both English and French. The consolidated version is the most current, incorporating all amendments.
Legislation structure
Acts
Canadian federal Acts are organized into:
- Parts — major divisions of the Act
- Sections (s) — numbered provisions (e.g., s 21, s 30)
- Subsections (ss) — numbered sub-provisions (e.g., s 20(1))
- Paragraphs (para) — lettered sub-items (e.g., s 20(1)(a))
Regulations
Regulations follow the same structure. They are cited with their registration number (e.g., SOR/98-282 = Statutory Orders and Regulations, registered in 1998, number 282).
Regulatory structure in Canada
Constitution Act → Parliament → Food and Drugs Act
↓
Governor in Council
↓
Medical Devices Regulations (SOR/98-282)
↓
Health Canada (MDD)
↓
Guidance Documents / Policies / Decisions
Acts are passed by Parliament and can only be amended by Parliament.
Regulations are made by the Governor in Council (Cabinet) under powers delegated by an Act. They can be amended more easily than Acts.
Guidance documents are published by Health Canada and represent Health Canada's interpretation of the legislation. They are not legally binding, but following them is the most reliable way to achieve compliance.
Finding the current version
Use the consolidated version at laws-lois.justice.gc.ca — it incorporates all amendments. You can also browse the amendment history to see what changed and when.
Canada Gazette
Proposed and final amendments to regulations are published in the Canada Gazette (canadagazette.gc.ca):
- Canada Gazette, Part I — proposed regulations open for public comment
- Canada Gazette, Part II — final regulations (in force)
Subscribing to Canada Gazette alerts is a good way to stay informed of regulatory changes affecting medical devices.