Asia
The document describes in detail the aspects to be taken into account when preparing a site master file. Table of Contents Introduction The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance...
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 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...
COVID-19
The article provides an overview of the existing regulatory framework and highlights the key points to be considered. Table of Contents Regulatory Background The present guidance covers the matters related to the 510(k) submissions for photobiomodulation (PBM)...
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...
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