What are the mandatory Requirements on medical device labels in India? (Health & Beauty - Health Services)

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Item ID 9637361 in Category: Health & Beauty - Health Services

What are the mandatory Requirements on medical device labels in India?


Mandatory requirements for medical device labels in India include the product name, batch/lot number, manufacturing and expiry dates, manufacturer/importer details, intended use, storage conditions, warnings, and BIS standard compliance. Labels must align with Medical Device Rules (MDR) 2017, be legible, and primarily in English to ensure safety, clarity, and regulatory adherence.

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Last Update : 27 December 2024 7:32 AM
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