Snapshot

The Fast Regulatory Pathways for IVDs pathway has been developed by the of India.

This pathway can be used where Covers all IVD classes per Indian Medical Device Rules 2017 and amendments: Class A (low risk), Class B, Class C, Class D (highest risk). Focused on evaluating: Analytical performance (sensitivity, specificity, accuracy, precision) under lab conditions. Clinical performance in local population settings (field testing). Performance consistency over time (reproducibility). Applies particularly to new IVD devices requiring licensing for import, local manufacturing, and clinical use approval..

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

Target time assessment is .