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How to get Medical Device Manufacturing license in India in 2023

Leave a Comment / Medical Device Rule /

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

Leave a Comment / CE Marking, Medical Device Rule /

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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Unique Device Identification (UDI)-How to Comply with FDA Guidelines

1 Comment / US FDA /

Unique Device Identification (UDI): How to Comply with FDA Guidelines? How to Comply with the UDI Rules of FDA? The implementation of the Unique Device Identification (UDI) system brings significant advancements to the medical device industry. The FDA’s UDI Rule mandates the inclusion of a unique device identifier on medical device labels, facilitating enhanced traceability,

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