Snapshot

The Expedited Class B Registration (EBR) Evaluation Route pathway has been developed by the of Kenya.

This pathway can be used where A Class B medical device may qualify for registration via the EBR route if it complies with the following conditions; • obtained approval from at least two of PPB’s independent reference regulatory agencies for a labelled use identical to that intended for marketing in Kenya; • marketed for at least three years in the above independent reference regulatory agency’s jurisdiction; • no safety issues globally associated with the use of the medical device(s) when used as intended by the Product Owner, in the last three years, defined as a) no reported deaths; b) no reported serious deterioration in the state of health of any person; and c) no open field safety corrective actions (including recalls) at the point of submission. OR Obtained approvals from at least three of PPB’s independent reference regulatory agencies for a labelled use identical to that intended for marketing in Kenya. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is .