Europe
Last Wednesday, as part of our monthly #WebinarWednesday series, RegDesk hosted an immensely informative presentation about recent changes to medical device regulations in the Eurasian Union. This month’s featured speaker, Eurasian regulatory expert Alexey...
Europe
The Bosnia and Herzegovina Agency for Medicines and Medical Devices, the country’s regulating authority in the sphere of healthcare products, has published a user guide dedicated to the national information system for medical devices. The present article describes the...
Europe
The Bosnia and Herzegovina Agency for Medicines and Medical Devices, the country’s regulating authority in the sphere of healthcare products, has published a user guide dedicated to the national information system for medical devices. General Information About...
EU MDR/IVDR
The Health Products Regulatory Authority (HPRA), the Irish regulating authority in the sphere of medicines and medical devices, has published a draft guidance document dedicated to new applications for wholesale distribution authorizations (WDAs), as well as...
Europe
The National Center for Expertise of Medicines and Medical Devices (NDDA), a Kazakhstan`s body responsible for the premarket assessment of medical devices, has published an official announcement about the implementation of the new importation and exportation rules for...
EU MDR/IVDR
The European Commission (EC), a union-wide authority responsible for medical devices regulations, has announced the launch of the first of six EUDAMED modules – the Actor registration module. Intended Purpose According to the official announcement published by...
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