EDA
The document clarifies the aspects related to pharmacovigilance and its importance for ensuring continuous safety of medical devices allowed for marketing and use in the country.
MHRA
The new article describes in detail the specific requirements an application should meet, as well as the relevant steps and procedures.
BfArM
The article addresses the aspects related to data protection in the context of digital health applications.
FDA
The article highlights the key points related to the application process and outlines the most important aspects to be taken into consideration by applicants.
FDA
The article provides an overview of the revised guidance document issued by the US authority to address certain regulatory matters and ensure legal clarity.
