Snapshot

The Expedited Class C Registration (ECR) pathway has been developed by the of Kenya.

This pathway can be used where Medical Devices including In-Vitro Diagnostics..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is Upon submission via PPB Online Portal, an application fee will be charged immediately. The application will be verified for eligibility for ECR, and the dossier will be verified for completeness. Once confirmed, the application will be accepted for evaluation. The evaluation fees will be charged at this point. In the event that the application does not qualify for ECR, the application will be required to be re-routed to the abridged or full evaluation route and the respective evaluation fees shall apply. Evaluation of the technical data/application by PPB is based on the data set submitted by the applicant. An input request will be issued to the applicant if clarification or additional information is required. A regulatory decision is made based on the outcome of PPB’s evaluation of the submitted dossier. Only applications which satisfy the registration requirements will be registered and listed on the PPB Online Registry. The stop-clock starts whenever PPB issues an input request and ends when PPB receives a complete and satisfactory response from the applicant..