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SaMD Regulatory Landscape in the US a…

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Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and …
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Clinical and Performance Evaluation u…

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Clinical evaluation of medical devices is a systematic and planned process that contributes to the co…
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Medical Devices-Regulatory Updates-As…

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Malaysia (MDA) 1. Malaysia’s MDA updates guidelines for testing medical face masks Malaysia’s M…
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Medical Devices USA/Europe Regulatory…

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EUROPE 1. First references of harmonised European standards in support of Regulation (EU) 2017/745…
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ICH E6 Good Clinical Practice Principles

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The ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers b…
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TGA’s Reclassification of Medic…

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The New Reclassification system for medical devices is round the corner to its effective date (25 Nov…
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