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...
Saudi Arabia
The article provides an overview of the regulatory requirements for clinical trials of medical devices. Table of Contents The Saudi Food and Drug Administration (SFDA), a country’s regulating authority in the sphere of healthcare products, has published...
EU MDR/IVDR
The new article highlights the key points related to a change of authorized representative, as well as the ones related to responsible persons and marketing surveillance. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European...
Brazil
The article provides an overview of the regulatory requirements for software as a medical device in Brazil. The Brazilian regulating authority in the sphere of medical devices (ANVISA), has published a questions and answers document dedicated to the regulatory...
FDA
The new article provides additional details regarding the submission process itself. In particular, it covers the aspects related to the content of the submission and also outlines the scope of changes for which the submissions are required. ...
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