Tag: Indian IVD Manufacturers

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IVDR Performance Evaluation Report and CE Marking Challenges

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Reghelps SRC Announces Focused Support for IVDR Performance Evaluation to Address Challenges Faced by Manufacturers New Delhi [India], January 19: The rapid growth of the in vitro diagnostics (IVD) sector presents huge opportunities for Indian manufacturers, but also significant challenges in demonstrating robust performance and achieving compliance with the European In Vitro Diagnostic Regulation (IVDR […]

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IVDR

IVDR CE Marking and the Challenges Faced by Indian IVD Manufacturers

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New Delhi [India], October 24: Indian IVD manufacturers face growing regulatory hurdles under the EU IVDR. I3CGLOBAL provides strategic CE Marking support to small, medium, and large-scale manufacturers in India to access the European market faster. With the enforcement of the EU IVDR Regulation 2017/746, Indian in vitro diagnostic (IVD) device manufacturers are facing significant challenges […]

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