In vitro diagnostics Licencing in India( www.ubio.in)

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Information about In vitro diagnostics Licencing in India( www.ubio.in)

Published on March 17, 2008

Author: bishorvi

Source: slideshare.net

Description

in vitro diagnsotic kits licencing and regulatory procedure in India www.ubio.in

In-vitro Diagnostics Licensing in India In-vitro Diagnostics and Drug Licensing Procedures in India

In-vitro Diagnostics Licensing in India

In-vitro Diagnostics and Drug Licensing Procedures in India

Used in HIV HBsAg HCV Blood grouping reagents Malaria tests interpreted as less critical than others All other devices are non-critical Critical Devices

Used in

HIV

HBsAg

HCV

Blood grouping reagents

Malaria tests

interpreted as less critical than others

All other devices are non-critical

Critical Devices

Critical Devices Licensing

Critical Devices Licensing

Test manufacturing license not needed Test batch evaluation not needed Inspection by central authorities not needed Application filed to state drug offices Non-Critical Devices

Test manufacturing license not needed

Test batch evaluation not needed

Inspection by central authorities not needed

Application filed to state drug offices

Non-Critical Devices

Consultancy support for drug licensing Preparation of application and documents Evaluation of project plan for compliance Audit facilitation Co-ordination with regulatory agencies for required approvals Fire Safety Pollution/Environmental Control Biomedical Waste Disposal We also provide full project life-cycle consultancy for IVD manufacturing Details at http://www.ubio.in/professional-services/ ubio in Licensing

Consultancy support for drug licensing

Preparation of application and documents

Evaluation of project plan for compliance

Audit facilitation

Co-ordination with regulatory agencies for required approvals

Fire Safety

Pollution/Environmental Control

Biomedical Waste Disposal

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

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

ubio in Licensing

www.ubio.in

www.ubio.in

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