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 document describing the way the Interim Order on medical devices, recently issued by the authority, should be applied. The initial document implements a set of...
The Health Canada, the Canadian regulating authority in the sphere of medical devices, issued an interim order concerning the importation and marketing of medical devices during the outbreak of the Coronavirus Disease 2019 (COVID-2019) caused by the virus “SARS-CoV-2”...
The Health Canada, the Canadian authority responsible for medical devices regulation, issued guidance dedicated to the application for a new license of making amendments to existing one for private label medical device. The document is intended to assist all parties...
