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Medical Device Rule

Explore the latest updates on Medical Device Rule in India. Our comprehensive guide covers the rules, compliance, and important insights. MedDev Experts

How to get Medical Device Manufacturing license in India in 2023

How to get Medical Device Manufacturing License in India in 2023 Medical Device Manufacturing License in India Medical Device Rule, 2017 came into force to govern the import, manufacture, sale and distribution of Medical Devices including In-Vitro Diagnostic Devices in India. The Medical Device Rule is introduced to ensure medical devices’ safety, effectiveness, and quality […]

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EU Declaration of Conformity: How to Comply with new Medical Device Regulation (EU) 2017/745

EU Declaration of Conformity: How to Comply with new Medical Device Regulation (EU) 2017/745 Overview of Declaration of Conformity: The EU Declaration of Conformity is an official document through which the manufacturer confirms that the device meets the essential requirements mentioned in Annex IV of Regulation (EU) 2017/745 of the European Parliament and of the

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