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Philippines (FDA) 1. Addendum to FDA Circular No. 2021-002 Re: Full Implementation of Administrati…
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EUROPE 1. Clarification on “first certification for that type of device” and corresponding procedu…
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The fast evolution of medical technology and the essential role of medical devices in the health care…
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The Regulation (EU) 2017/745 on medical devices requires that the manufacturer shall draw up a summar…
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Over the course of drug development, it is important for sponsors to develop a scientifically robust …
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The Therapeutic Goods Administration (TGA) regulates software-based medical devices; including softwa…

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