
Feb 2, 2023
Saudi Arabia
The new article provides an overview of the regulatory requirements for the clinical evaluation of medical devices based on novel technologies. In particular, the document describes the three main components of clinical evaluation and highlights the most important...
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Feb 2, 2023
Saudi Arabia
The article provides an overview of the applicable regulatory requirements and highlights the key points associated thereto. Table Of Contents: The Saudi Food and Drug Administration (SDFA), a country’s regulating authority in the sphere of healthcare products, has...
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Feb 2, 2023
Malaysia
The new article highlights the aspects related to the scope of information and documentation the authority expects to be included in requests from interested parties. Table Of Contents: The Medical Device Authority (MDA), a Malaysian regulating authority, has...
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Feb 2, 2023
FDA
The new article provides an overview of the revised guidance document and outlines the key points associated thereto. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
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Feb 2, 2023
Australia and Oceania
The article provides an overview of the new classification rules for certain medical devices recently introduced in Australia. Table Of Contents: The guidance is intended to provide medical device manufacturers and other parties involved in manufacturing medical...
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