Health Canada • Regulations
Food and Drug Regulations spotlight
These summaries anchor the specific parts that most teams need when aligning Canadian submissions, site transfers, and vigilance updates.
Food and Drug Regulations (C.R.C., c. 870)
Detailed requirements for clinical trials, establishment licensing, GMP, labeling, and pharmacovigilance tied to the Food and Drugs Act.
- Divisions 1A and 2 called out for establishment licensing and GMP release requirements.
- Evidence expectations for DIN/NOC filings and lot release programs.
Medical Devices Regulations (SOR/98-282)
Risk-class specific controls, QMS requirements, and bilingual labeling obligations for medical devices and IVDs.
- Class II–IV licensing workflow plus investigational testing authorization flow.
- CMDR/ISO 13485 alignment callouts that map to the Assyro quality workspace.
Special Access & Clinical Trial Regulations
Provisions covering SAP requests, modernized clinical trial rules, and COVID-era interim orders now folded into permanent regulations.
- Highlights SAP decision timelines and documentation packages.
- Shows where interim order language has been consolidated.