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Health Canada Proposed Rules

Smart & Biggar

Proposed Ministerial Reliance Order would allow Health Canada to rely on decisions of foreign trusted regulators

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On December 19, 2025, the Minister of Health announced the launch of consultations on two key regulatory initiatives referenced in Health Canada’s Red Tape Review report: (i) the Ministerial Reliance Order and (ii) clinical...more

Smart & Biggar

Proposal for modernizing clinical trial framework aims to improve access to new and innovative therapies in Canada

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On December 20, 2025, Health Canada launched a consultation on modernizing the framework for clinical trials involving drugs for human use, including pharmaceuticals, biologics, radiopharmaceuticals, and cannabis. This...more

Bennett Jones LLP

Incoming Lithium-Ion Battery Regulations—Health Canada Wants to Hear from You

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On December 2, 2025, Health Canada published a Notice of Intent regarding proposed regulations for lithium-ion batteries and consumer products containing lithium-ion batteries (collectively, Lithium-Ion Battery Products)...more

Smart & Biggar

Medical Devices updates: Phase II consultation on Medical Devices Regulations amendments, medical device licences guidance and...

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On November 17, 2025, Health Canada proposed Phase II amendments to the Medical Devices Regulations (MDR). The first phase of amendments came into force on December 14, 2024 and relate to recalls, modernizing medical device...more

Bennett Jones LLP

Health Canada Proposes Amendments to MDEL Holders and Applicants

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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

Blake, Cassels & Graydon LLP

Consultation sur les modifications proposées aux exigences relatives aux licences d’établissement d’instruments médicaux

Le 8 novembre 2025, Santé Canada a publié le Règlement modifiant le Règlement sur les instruments médicaux (licences d’établissement) (le « projet de règlement ») dans La Gazette du Canada, lequel propose des changements aux...more

Smart & Biggar

Health Canada publishes Guide to the precision regulating authorities under the Food and Drugs Act

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In March 2025,  Health Canada published a Guide to the precision regulating authorities under the Food and Drugs Act. The Guide sets out the principles, policies, considerations and standards that Health Canada should follow...more

Smart & Biggar

Health Canada proposes to amend the Food and Drug Regulations and Medical Devices Regulations to address shortages

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On December 28, 2024, Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages (see our previous article regarding Health Canada’s...more

Bennett Jones LLP

Health Canada Consultation on Proposed Amendments to Address Drug and Medical Device Shortages in Canada

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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

Stikeman Elliott LLP

New Regulatory Amendments Under the Food and Drugs Act: Addressing Drug and Medical Device Shortages in Canada

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On December 28, 2024, Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments to the Food and Drug Regulations, CRC, c 870 and the Medical Devices...more

Smart & Biggar

Health Canada and CADTH launch new initiative to provide early parallel scientific advice

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On February 28, 2019, Health Canada released a Notice to Industry announcing the Early Parallel Scientific Advice initiative. Currently, Health Canada and the Canadian Agency for Drugs and Technologies in Health (CADTH) offer...more

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