Health Canada, the Canadian regulating authority in the sphere of medical devices, has published guidance on summary reports and issue-related analyses for medical devices. Summary Reports: Additional Aspects The present Health Canada guidance details the regulatory...
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...
Health Canada, the country’s regulating authority in the sphere of medical devices, has published updated guidance on incident reporting for medical devices. The present document supersedes the previous version issued by the authority earlier in October 2011. Due to...
Health Canada has published a guidance dedicated to the applications for medical devices under the Interim Order for use in relation to the COVID-19. Interim Order (IO) constitutes a special document issued to accelerate the implementation of vitally important rules...
Health Canada, the Canadian regulating authority, has published a notice to the medical devices manufacturers, dedicated to the technical requirements for decontamination devices employing ultraviolet (UV) radiation. The scope of the document covers both...