Apr 17, 2023
IMDRF
The document highlights the key points regarding the regulatory approach to be applied with respect to cybersecurity-related matters associated with legacy medical devices. Table Of Contents: The International Medical Devices Regulators Forum (IMDRF), a voluntary...
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Mar 14, 2023
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...
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Feb 20, 2023
MDCG
The article provides an overview of the revised guidance document addressing the classification rules. Table Of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for the medical devices regulatory framework,...
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Feb 9, 2023
Asia
The new article addresses the aspects related to reporting incidents associated with combination products allowed for marketing and use in Malaysia. Table Of Contents Incident Reporting: Key Points The document further highlights the key points associated with...
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Feb 7, 2023
Asia
The new article addresses the matters related to the applicable review timelines, fees payable, and changes to registered combination products. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of medical devices, has...
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