The Great Green North: A Discussion on Canada’s Environmental Regulations
On March 5, 2026, Environment and Climate Change Canada (ECCC) and Health Canada (HC) published the Framework for the Risk Assessment of Manufactured Nanomaterials under the Canadian Environmental Protection Act, 1999....more
As previously reported, in December 2024, Health Canada published its agile licensing amendments to the Food and Drug Regulations (FDRs). The amendments included authorities that will come into force on April 1, 2027,...more
On November 8, 2025, the Department of Health published proposed amendments to the Medical Devices Regulations, SOR/98-282 (MDR) with a specific focus on the medical device establishment licence (MDEL) regime. The proposed...more
En réponse aux préoccupations des parties prenantes au sujet des processus administratifs obsolètes et trop prescriptifs, le gouvernement du Canada a lancé un examen du fardeau administratif dans tous les ministères et...more
As we previously reported, Health Canada completed consultation on its draft guidance for determining medical device application type. The Medical Devices Regulations (MDR) outline five scenarios in which a medical device,...more
In July 2025, the Government of Canada launched a “Red Tape Review” across all federal departments to modernize regulatory frameworks and support economic growth. In this context, Health Canada and the Public Health Agency of...more
Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more
The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) jointly issued a guidance document entitled, “Good Machine Learning Practice for...more