1

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

ss-321
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. https://www.dueranconsultancy.com/blog/medical-device-labelling-compliance/
Report this page

Comments

    HTML is allowed

Who Upvoted this Story