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...
CDRH
This article highlights the details of the adverse event reporting regulations in the European Union (EU) and the United States (US), their similarities, differences, and their impact on medical device safety. Table of Contents Ensuring the safety and effectiveness of...
Asia
This article talks about the Unique Device Identification System for Medical Devices, its timelines and regulatory requirements across various countries. Table of Contents The use of medical devices is essential in healthcare, with millions of devices being used...
EU MDR/IVDR
This article highlights the importance of GSPR compliance for obtaining medical device approval in the European Market. Table of Contents The European Union (EU) has implemented stringent regulations and requirements for the approval and launch of medical devices...
China
The new article describes in detail the approach to be applied with respect to documentation related to informed consent. Table of Contents Class II medical devices are an important segment of the medical device industry.These moderate-risk devices include many...
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...
