North America
This article was updated June 2, 2025. The FDA finalized guidance in 2019 regarding placebos and blinding. FDA’s Guidance on Placebos:A placebo is an inactive substance or procedure used in clinical trials to determine whether participant responses result from...
China
Overview of China’s National Medical Products Administration (formerly CFDA), their reform, medical device registration, drug registration, …
Europe
This article was updated June 2, 2025. 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...
Europe
This article was updated June 2, 2025. Ireland’s medical device regulations are harmonized with the European Union’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The Health Products Regulatory Authority...
Europe
Portugal, as a member of the European Union follows the same medical device classification as all other EU member states. In the EU classification system we can distinguish four different medical device classes: Class I, Class IIa, Class IIb, and Class III. Class 1...
Europe
Medical devices in the EU, including Hungary, are classified into four classes based on their risk: I, IIa, IIb, and III. Medical devices belonging to Class I are associated with the lowest risk to the human body, while Class III devices are associated with the...
