RegDesk News/Info
The article outlines the key points associated with the classification rules for medical devices.
BfArM
The Federal Institute for Drugs and Medical Devices (BfArM), the German regulating authority in the sphere of healthcare products, has published a notice dedicated to notifications of interruptions or terminations of the supply of medical devices the parties responsible should submit in order to communicate the crucial information to all the stakeholders involved.
Korea
The document provides an overview of the existing legal framework for innovative medical devices intended to be marketed and used in Korea.
FDA
The article provides a brief overview of the applicable regulatory requirements set forth under the existing legal framework.
FDA
The new article describes in detail the applicable performance criteria to be taken into consideration by the parties responsible for medical devices covered by the scope of the guidance in order to ensure continued safety and proper performance of the latter.
