BfArM
The article outlines the key points related to reporting serious adverse events in the context of clinical trials.
EU
The article describes in detail the regulatory approach to be applied in the context of the importation and distribution of medical devices in the EU, focusing on the obligations of the parties involved.
Turkey
The article provides a general overview of the current regulatory framework for the distribution and advertising of medical devices intended to be marketed and used in Turkey.
Africa
This article highlights what CE marking is, how to obtain it, and the steps to follow to comply with EU regulations. Table of Contents Medical devices manufacturers willing to market products in the European Union (EU), must comply with the regulations established...
Canada
This article highlights he current regulations for medical devices in Canada, the process of registering compliant devices, potential changes being considered, and the potential impact on stakeholders. Table of Contents The use of medical devices is essential in...
