Snapshot

The Immediate Class B Registration (IBR) Evaluation Route 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 a verification review (a recognition pathway).

Target time assessment is Upon submission via PPB online Portal (portal.pharmacyboardkenya.org, the medical device will be registered immediately and will be listed on the PPB Online registry within an hour. An email notification regarding the successful registration of the device will be sent within 48 hours of submission in PPB online Portal. The total fees will also be charged immediately upon successful submission for this route. As devices are registered immediately upon successful submission, applicants are reminded to ensure the application fulfills ALL the eligibility criteria and that all the required information is entered correctly and accurately. PPB will verify the documents submitted in PPB online Portal after successful submission. Based on the intended use of the device by the Product Owner, additional registration conditions may be imposed post-registration. The IBR evaluation route facilitates immediate market access for the medical devices. Any IBR application which fails to fulfill the ALL the registration criteria specified for the IBR evaluation route or a non-Class B medical device submitted via the IBR evaluation route would result in cancellation of the registration and the registration fee will NOT be refunded. .