FDA
The article covers the key points related to the existing regulatory requirements and highlights the most important aspects to be considered by the parties involved. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
Asia
The document outlines the key points related to the applicable classification requirements for specific types of medical devices. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of healthcare products, has published a...
Asia
The article provides an overview of the regulatory requirements related to the content of special communications to be issued by medical device manufacturers in order to inform about the issues associated with the products they are responsible for. Table of Contents...
FDA
The new article addresses the aspects related to enforcement actions the authority may take, and also describes the various types of standards. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
Thailand
The article provides an overview of the draft law dedicated to the quality system for medical devices intended to be marketed and used in Thailand. Table of Contents Thailand’s regulatory authority in the sphere of healthcare products has published a document...
