Canada
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...
Canada
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...
Canada
Health Canada has published a notice summarizing the most important aspects related to the Interim Orders (IOs) in the context of the outbreak of COVID-19 and special regulatory measures associated thereto. The document is intended to provide medical device...
Canada
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...
Canada
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, issued a compliance program describing the inspections related to CDER-led or CDRH-led combination products. The document provides the requirements for different...
Canada
The Health Products and Food Branch of Health Canada, the Canadian regulating authority in the sphere of medical devices, issued a notice on the expansion of the medical device Regulatory Enrolment Process (REP) pilot program. Regulatory Enrolment Process: Regulatory...
