Our Blog

Never miss a thing! The latest regulatory news and updates are always on our feed.

Slider
The EMA Published Draft Guidance on DDC Products.
European Medicines Agency issued a new draft guidance related to drug-device combinations. This particular regulation specifies the necessary documents for the application for marketing authorization for these types of...
A Guide to Enter Your Medical Device in Italy
Medical devices in Italy are subject to the same regulations as all countries in the European Union (EU) which were implemented in 2017. Here, you can find out more information on the EU MDR and IVDR regulation....
Our Guide to Registering Medical Devices in Croatia
In Croatia, the governmental body responsible for regulating medical devices is the Agency for Medicinal Products and Medical Devices (HALMED). Devices are categorized into the following classes based on the risk they...