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Guiding Principles for Good Machine L…

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The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and He…
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ICH Guideline E8 (R1) on General Cons…

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Clinical studies of medicinal products are conducted to provide information that can ultimately impro…
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Switch of the legal status of a medic…

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Principles and procedures for a ‘switch’ of the legal status of a medicinal product from prescription…
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Registration of Drug-device Combinati…

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NMPA Notice on Matters Concerning the Registration of Drug-device Combination Products With the vi…
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Medical Devices – USA/Europe Re…

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EUROPE 1. Clarification on “first certification for that type of device” and corresponding procedu…
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Medical Devices-Asia Regulatory Updat…

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China (NMDA)   1. 2th China International Medical Device Regulatory Forum held in Wuhan Spon…
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