Snapshot

The Class B Medical Device 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 two 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 .