Snapshot

The Class C, D and IVDs - Abridged Evaluation Route pathway has been developed by the of Kenya.

This pathway can be used where A medical device that has obtained at least three reference regulatory agency approval for a labelled use identical to that intended for marketing in Kenya at the time of submission will qualify for the abridged evaluation route..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is .