The Medical Devices Introductory Course 2020

The Organisation for Professionals in Regulatory Affairs

Key Players

Regulatory Agency:

www.hc-sc.gc.ca

•Health Canada (HC) provides federal oversight of food, drugs, devices, biologic and genetic therapies, natural health products and other health related products in Canada •Established in 1919 as the Federal Department of Health and first introduced the Food & Drug Act (F&DA) in 1920 •The Health Products & Food Branch includes the following sections relevant to Combination Products: • Therapeutic Products Directorate (TPD) – responsible for drugs and devices • Biologics & Genetic Therapies Directorate (BGTD) – responsible for biological drugs derived from living sources • Health Products & Food Branch Inspectorate (HPFBI) – responsible for enforcement, compliance and inspections (all product areas) • Medical Devices Bureau (MDB) – under the TPD, responsible for administration of the Medical Device Regulation (MDR) • Therapeutic Products Classification Committee (TPCC) – appointed by Director General of the TPD for Combination Product classification determinations and policy