Europe
The new document describes in detail the aspects related to the existing types of clinical trials, as well as the way an interested party should submit an application. Table of Contents Switzerland’s regulating authority in the sphere of healthcare products,...
FDA
The new article highlights the aspects related to various types of modifications to be introduced to a medical device based on the information included in the initial submission and also provides an overview of the regulatory matters associated with the Modification...
Saudi Arabia
The new article highlights the aspects related to the changes to the design of a medical device and the potential impact thereof. Table of Contents The Saudi Food and Drug Administration (SFDA), a county’s regulatory agency in the sphere of healthcare products, has...
IMDRF
The new article addresses the aspects related to the initial design development stage in terms of design and controls intended to ensure a medical device’s continued safety and proper performance. In particular, the article outlines the main responsibilities of...
FDA
The new article addresses the aspects related to the content of a monitoring plan, as well as the follow-up procedures and the way they should be documented. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
Europe
The new article describes in detail special projects the authority intends to implement in order to introduce specific needs associated with the products based on innovative technologies. Table of Contents The Medicines and Healthcare Products Regulatory Agency...
