Saudi Arabia
The new article addresses the aspects related to the quality management system in the context of medical devices based on innovative technologies. Table of Contents The Saudi Food & Drug Authority (SFDA), a country’s regulatory agency in the field of healthcare...
Asia
The article highlights the key points related to the regulatory requirements for the online importation approval process. Table Of Contents: The National Health Regulatory Authority (NHRA), Bahrain’s regulatory agency in the sphere of healthcare products, has...
COVID-19
The new article addresses the matters related to modifications to photobiomodulation devices, provides definitions of the most important terms and concepts used, and also describes warnings and precautions to be included in labeling. Table of Contents The Food and...
Asia
The new article addresses the matters related to the applicable review timelines, fees payable, and changes to registered combination products. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of medical devices, has...
FDA
The article provides an overview of the official guidelines dedicated to classification rules and requirements for medical devices intended to be marketed and used in the US. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating...
