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...
Saudi Arabia
The new article highlights the aspects related to the clinical evaluation of medical devices based on innovative technologies. Table Of Contents: The Saudi Food and Drug Authority (SFDA), a country’s regulatory agency in the sphere of healthcare products, has...
FDA
The new article addresses the aspects related to the application of wireless technologies that are widely used in medical devices nowadays, as well as to certain safety-related matters. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
Asia
The article describes the general principles outlined in the respective policy adopted by the authority and explains the approach the authority intends to apply. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP), a country’s agency in the sphere of...
FDA
The new article highlights the key points related to molecular diagnostic tests and describes the recommendations provided by the authority in this respect. Table Of Contents The Food and Drug Administration (FDA or the Agency), the UA regulating authority in the...
