The new article highlights the key points related to a change of authorized representative, as well as the ones related to responsible persons and marketing surveillance. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European...
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. However, there are slight differences in the regulatory...
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 pose toward on the human body: Class I, Class IIa,...
In Bulgaria, the institution that regulates medical devices is the Bulgarian Drug Agency (BDA). On June 12, 2007 the Bulgarian Parliament created the Law on Medical Devices, which is the policy that is currently used to govern the registration of medical devices...
As the patents for current biologics expire and the biosimilar industry begins to gain traction it is important to look at the future of the biosimilar market while noting hold-backs within the US manufacturing and approval processes. According to Research and...
EU MDR/IVDR
