HPRA Guidance on Fees for Human Products: Medical Devices
The new article addresses the matters related to medical devices and associated fees.
The new article addresses the matters related to medical devices and associated fees.
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Authority (HPRA), the Irish regulating authority in the sphere of medicines and medical devices, has published a draft guidance document dedicated to new applications for wholesale distribution authorizations (WDAs), as well as...
The Medicinal and Healthcare products Authority (MHRA) has published an updated version of the guidance describing the new medical device regulations related to Brexit. In particular, the amended document provides additional details regarding the way medical devices...
The Health Products Regulatory Authority (HPRA) of Ireland has shared details of its efforts to mitigate the risk of disrupting the supply of medical devices caused by a no-deal Brexit. In cooperation with the Department of Health and the Health and Safety Executive...
Ireland medical device regulations are unified with other European Union countries and follow the same EU MDR and IVDR regulation. However, each country has their own Regulatory Authority (RA). In the case of Ireland, such RA is HPRA. Overview All medical...