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:

References:

[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