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Slide 1: In­vitro  Diagnostics  Licensing in  India In-vitro Diagnostics and Drug Licensing Procedures in India © 2008 ubio. All rights reserved. 1
Slide 2: Critical Devices  Used in HIV HBsAg HCV Blood grouping reagents Malaria tests interpreted as less critical than others  All other devices are non­critical © 2008 ubio. All rights reserved. 2
Slide 3: Critical Devices Licensing © 2008 ubio. All rights reserved. 3
Slide 4: Non­Critical Devices  Test manufacturing license not  needed  Test batch evaluation not needed  Inspection by central authorities not  needed  Application filed to state drug offices © 2008 ubio. All rights reserved. 4
Slide 5:  Consultancy support for drug licensing ubio in Licensing  We also provide full project life­cycle consultancy  for IVD manufacturing Details at http://www.ubio.in/professional­services/ © 2008 ubio. All rights reserved. Preparation of application and documents Evaluation of project plan for compliance Audit facilitation Co­ordination with regulatory agencies for required  approvals Fire Safety Pollution/Environmental Control Biomedical Waste Disposal 5
Slide 6: www.ubio.in © 2008 ubio. All rights reserved. 6