April 18, 2018

US prepares for unique code for devices

The US Regulatory Agency FDA is preparing all the required information in view of the adoption of the unique code for medical devices and the relevant database (GUDID – Unique Device Identification Database). The information to be published within summer, will support the registrations of medical devices. The US Agency has recommended that companies check the data to be included […]

Di Renzo Regulatory Affairs News 0 27 sec read
April 14, 2018

EMA redistributes UK DCP portfolio

In view of the Brexit, the European Medicine Agency has redistributed the portfolio of the medicinal product for human and veterinary use authorized at central level sharing more than 350 products currently managed by British agencies to rapporteurs and co-rapporteurs of other countries. At the moment, the staff of the British regulatory Agency (MHRA) and Veterinary Medicines Directorate (VMD) have […]

Di Renzo Regulatory Affairs News 0 30 sec read