Food and Drug Regulations
Overview
The Food and Drug Regulations (CRC, c 870), made under the Food and Drugs Act, are the principal regulations governing drugs and biologics in Canada. For most medical devices, the Food and Drug Regulations do not apply. However, they are relevant for:
- Combination products where the drug or biologic is the primary mode of action — in these cases, the Food and Drug Regulations (not the MDR) govern the regulatory pathway
- Drug components of integral drug-device combination products
- Sterile manufacturing — some provisions of the Food and Drug Regulations (particularly Part C, Division 2, Schedule F) set standards that are cross-referenced in device guidance
Combination products
For combination products regulated as drugs (because the drug is the primary mode of action), the device component is reviewed as part of the drug submission under the Food and Drug Regulations. The MDR does not apply to the combination product as a whole, but Health Canada may apply equivalent device safety standards through the drug review process.
See Combination Products (Drug-Device) for the full decision process.
Official source