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in vitro diagnsotic kits licencing and regulatory procedure in India www.ubio.in
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© 2008 ubio. All rights reserved. 1
In-vitro Diagnostics Licensing in India
In-vitro Diagnostics and Drug Licensing Procedures in India
© 2008 ubio. All rights reserved. 2
Used inHIVHBsAgHCVBlood grouping reagentsMalaria tests
interpreted as less critical than othersAll other devices are non-critical
Critical Devices
© 2008 ubio. All rights reserved. 3
Critical Devices Licensing
© 2008 ubio. All rights reserved. 4
Test manufacturing license not neededTest batch evaluation not neededInspection by central authorities not
neededApplication filed to state drug offices
Non-Critical Devices
© 2008 ubio. All rights reserved. 5
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
© 2008 ubio. All rights reserved. 6
www.ubio.in