Snapshot

The Approval Process for Application received in hard copy with respect to In Vitro Diagnostics pathway has been developed by the of India.

This pathway can be used where Manufacture for sale or distribution of Class A or Class B In Vitro Diagnostic Medical Devices. In vitro diagnostic medical devices shall be classified on the basis of risk parameters as specified in Part II of the First Schedule, as under: Low risk - Class A; Low moderate risk- Class B; Moderate high risk- Class C; High risk- Class D..

This pathway facilitates activities during development.

It is an abridged review (a reliance pathway).

Target time assessment is .