Market Authorization of In-vitro Diagnostic Devices in India

List of Notified In-vitro Diagnostic Devices (IVDs):

1.     IVD for HIV

2.     IVD for HBsAg

3.     IVD for HCV

Regulatory Pathway for IVDs:



[1]  The Drugs And Cosmetics Act And Rules, Department of Health, Government of India

[2]  Guidance Document - Requirements for Conducting Clinical Trial(s) of Medical Devices in India

[3]  Guidance document on application for grant of Licence in Form-28 for manufacture of Medical Devices in India under CLAA Scheme

[4]  Schedule M-IV_GMP for In-vitro Diagnostics