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India CDSCO Amends Sterilization Rules: What Removing the Loan Licence Means for Medical Devices
India's CDSCO has amended the Medical Devices Rules, 2017, effective August 24, 2024, removing the 'loan licence' requirement for manufacturers who outsource device sterilization. This episode explains the amendment, details the new mandatory labeling requirements for sterilized products, and outlines the practical steps that regulatory and quality teams must take during the six-month transition period to ensure compliance. Key Questions: - What was the 'loan licence' requirement for medical device sterilization in India? - How does the CDSCO's August 2024 amendment change the rules for…
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