Canada’s regulatory framework requires careful navigation of both device licensing and establishment licensing. With our combined industry and legal expertise, we ensure your medical devices meet Health Canada’s requirements, enabling smooth market entry and sustained compliance.
Learn MoreHealth Canada is authorized to inspect any holder of a Medical Device Establishment Licence (MDEL) to verify compliance with the Food and Drugs Act and the Medical Devices Regulations (MDR). This section highlights the principal responsibilities and obligations of MDEL holders
Learn MoreHealth Canada requires all manufacturers of Class II, III, and IV medical devices, whether holding existing licences or applying for new or amended licences, to implement and comply with ISO 13485:2016. As part of this requirement, manufacturers must submit a valid ISO 13485:2016 certificate to Health Canada. Importantly, Health Canada will only accept ISO 13485 certificates issued under the Medical Device Single Audit Program (MDSAP).
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