Canada
Health Canada, the Canadian regulating authority in the sphere of healthcare products, has issued guidance on summary reports and issue-related analyses for medical devices. Regulatory Background The regulatory requirements for importation, distribution and marketing...
Canada
The Health Canada, the Canadian authority responsible for medical devices regulation, issued guidance describing the way the Interim Order on medical devices, recently issued by the authority, should be applied. The initial document implements a set of additional...
North America
Health Canada, the Canadian medical regulating authority, announced that new requirements, which was under development since 2018, came into effect this week. The scope of new requirements covers issues related to cybersecurity threats. In accordance with applicable...
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