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In-vitro Diagnostics Licensing in India

In-vitro Diagnostics and Drug Licensing Procedures in India

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Used inHIVHBsAgHCVBlood grouping reagentsMalaria tests

interpreted as less critical than othersAll other devices are non-critical

Critical Devices

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Critical Devices Licensing

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Test manufacturing license not neededTest batch evaluation not neededInspection by central authorities not

neededApplication filed to state drug offices

Non-Critical Devices

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Consultancy support for drug licensingPreparation of application and documentsEvaluation of project plan for complianceAudit facilitationCo-ordination with regulatory agencies for required approvals

Fire SafetyPollution/Environmental ControlBiomedical Waste Disposal

We also provide full project life-cycle consultancy for IVD manufacturing

Details at http://www.ubio.in/professional-services/

ubio in Licensing

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www.ubio.in