Canada: Updated Medical Devices Regulations (SOR/98-282)

Health Canada has released the consolidated Medical Devices Regulations (SOR/98-282) incorporating amendments under SOR/2024-238, with key changes effective 01 January 2026. The updated framework strengthens regulatory oversight, recall authority, and post-market controls for medical devices in Canada.

The Minister now has expanded authority to impose or amend terms and conditions (T&Cs) on Class II, III, and IV device licences at any stage of the product lifecycle, based on risk, uncertainty, and feasibility considerations. For in vitro diagnostic (IVD) devices, lot release testing data must be submitted and confirmed by Health Canada before sale when required as a licence condition.

The amendments modernize the recall framework, clarify importer and establishment licence (MDEL) obligations, and introduce stricter distribution record-keeping and shortage reporting requirements. Establishment licence holders must submit annual reviews before April 1 and maintain documented procedures for handling, storage, installation, corrective actions, and regulatory reporting.

The regulations also formalize emergency flexibilities introduced during COVID-19, enabling accelerated access pathways during public health emergencies.

These updates enhance Canada’s risk-based oversight, lifecycle monitoring, and patient safety protections across the medical device sector.
Region: Canada
Source: https://laws-lois.justice.gc.ca/PDF/SOR-98-282.pdf
https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/FullText.html