Jun 12, 2023
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,...
Read More
Apr 18, 2023
Europe
The article highlights the key points related to the regulatory requirements for performance studies involving in vitro diagnostic medical devices. Table of Contents Swissmedic, a Swiss Agency for Therapeutic Products, has published an information sheet dedicated to...
Read More
Apr 6, 2023
EU MDR/IVDR
Medical devices are an integral part of healthcare, and their safety and efficacy are critical to ensure patient well-being. In 2017, the European Parliament and Council adopted the new Medical Devices Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) to...
Read More
Mar 23, 2023
Asia
The new article highlights the aspects related to the recalls and withdrawals initiated by the authority or by a party responsible for a medical device itself. Table of Contents The Turkish regulating authority in the sphere of healthcare products has recently...
Read More
Mar 6, 2023
Asia
The article provides an overview of the regulatory requirements related to recalls and withdrawals for general and in vitro diagnostic medical devices allowed to be marketed and used in Turkey. Table of Contents The Turkish regulatory agency in the...
Read More