Saudi Arabia
The new article highlights the aspects related to managing the risks associated with medical devices based on novel technologies. Table of Contents The Saudi Food & Drug Authority (SFDA), a country’s regulatory agency in the field of healthcare products, has...
COVID-19
The new article describes in detail the aspects related to clinical trials, including the determination of study endpoints and duration, as well as follow-up schedule, statistical considerations, and adverse events monitoring. Table of Contents The Food and Drug...
COVID-19
The new article covers the general matters related to clinical investigations with photobiomodulation devices involved. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
Asia
The new article describes in detail the aspects related to registration that combination products should undergo in order to be allowed for marketing and use in the country. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the...
FDA
The new article covers the matters related to antigen diagnostic tests and explains the approach to be applied by the test developers in order to ensure the continued effectiveness of their devices. Table Of Contents: The Food and Drug Administration (FDA or the...
