Manufacturer registration scheme medical devices italian version italian edition medical devices directorate on amazoncom free shipping on qualifying offers manufacturer registration scheme medical devices italian version italian edition. So for example if we successfully register our medical device in italy we can market it as well in germany portugal and hungary another thing that manufacturers should look into is picking a quality management system one of the most popular choices in this regard is iso 13485 certification which is valid only for three years in opposition to other eu licenses which are valid for . Buy manufacturer registration scheme medical devices italian version by medical devices directorate isbn 9780113214273 from amazons book store everyday low prices and free delivery on eligible orders. The database of medical devices collects information related to all medical devices released in the italian territory by domestic manufacturers however the registration of medical devices by european or non european manufacturers who wish to distribute their medical devices in italy is limited to those belonging to classes higher than i the database of medical devices is an important . Re medical device registration process in italy class i and class ii medical devic my understanding is that the registration has to be done by a party thats resident in europe and has an official presence in italy as a us located company we have an authorized representative within europe and that company offers italian registration