Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical devices regulation, issued guidelines describing how medical device manufacturers shall apply for inclusion of the COVID-19 test in the national register of medicinal products...
Europe
The European Commission (EC), the EU authority responsible for medical devices regulation, issued a Q&A conformity document describing the approaches to verifying that medical devices and personal protective equipment (PPE) are allowed to be marketed and uses...
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...
FDA
The European Commission issued a Question and Answer document in order to provide medical device manufacturers with the information regarding the way the new Manufacturer Incident Report (MIR) Form shall be implemented. New Manufacturer Incident Report Form in Brief...
The Food and Drug Administration (FDA), the United States’ authority for medical devices regulation, issued home specimen collection molecular diagnostic template in order to provide medical device manufacturers with the recommendations related to the content of...
