
Feb 2, 2023
COVID-19
The new article highlights the aspects related to the use of tests developed by certified laboratories, as well as the ones being reviewed by the authority. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
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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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Feb 2, 2023
FDA
The new article describes the recommended content and highlights the key points to be considered in this respect. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a...
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Feb 2, 2023
FDA
The new article provides an overview of the regulatory requirements related to the information on human factors to be submitted when applying for marketing approval. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
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