Jan 16, 2023
FDA
The new article addresses the aspects related to the principles to be followed with respect to voluntary reporting, and also describes the approach the authority applies when determining the eligibility criteria to be considered. Table of Contents The Food and Drug...
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Nov 3, 2022
Brazil
The new article described in detail the aspects related to the evidence required for software products based on novel technologies, as well as to the determination of the regulatory status of the products depending on their functions and features. The Brazilian...
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Oct 27, 2022
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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Jun 9, 2022
Australia and Oceania
The article provides an overview of the current regulatory framework for the re-registration of medical devices in Malaysia and describes in detail the most important aspects to be considered when submitting a respective application. The Medical Device Authority...
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Mar 20, 2021
EU MDR/IVDR
The Health Products Regulatory Authority (HPRA), the Irish regulating authority in the sphere of medicines and medical devices, has published a draft guidance document dedicated to new applications for wholesale distribution authorizations (WDAs), as well as...
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