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...
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...
