Health Ministry Eases Medical Device Sterilisation Rules
· India · The Hindu, LiveMint
The Union Health Ministry has proposed amendments to the Medical Devices Rules, 2017, simplifying regulatory requirements for outsourced sterilisation. Manufacturers will no longer need a separate loan licence if the sterilisation facility holds a valid licence. The change aims to reduce paperwork, administrative burden, and compliance costs. A traceability requirement remains, with manufacturers needing to mention the sterilisation facility's licence number on labels. A six-month transition period has been provided for companies to adjust.
Why it matters
This reduces costs and delays for medical device manufacturers, potentially speeding up market access for essential healthcare products.
Read the original report — The Hindu
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