AI
The article provides an overview of the regulatory approach to be applied with respect to certain categories of innovative medical devices.
Medical Devices
EUDAMED (European Database on Medical Devices) is an essential information system for the European Union’s regulatory framework for medical devices.
Medical Devices
In the highly regulated world of medical devices and in vitro diagnostics (IVDs), ensuring compliance with international standards is critical for market access and patient safety.
Medical Devices
The European Commission’s Health Technology Assessment Regulation (HTAR) marks a significant step toward harmonizing health technology evaluations across EU member states.
Medical Devices
This article provides key insights to navigating China’s complex medical device regulatory landscape.
Medical Devices
This article provides key insights to navigating China’s complex medical device regulatory landscape.
