Search: rule 44
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August 2026
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LicencesMedical Devices Rules, 2017: no separate loan licence for outsourced sterilisation; EU added for clinical-investigation waiver, says Health Ministry
No loan licence for sterilisationRule changeThe Health Ministry says the Medical Devices Rules, 2017 have been amended. Under amended rule 44, a manufacturer that outsources sterilisation to a facility holding a valid licence under the Rules no longer needs a separate loan licence for that activity. Rule 63 now includes the European Union among the jurisdictions recognised for waiver of clinical investigation.
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