Snapshot

The Registration of In Vitro Diagnostic Devices pathway has been developed by the of Zanzibar.

This pathway can be used where In vitro diagnostic devices (Classes A-D).

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is Once an application has been accepted and evaluation fees paid the processing of application will take 270 calendar days. This will involve evaluation of applications, request for additional data/samples and clarification of some issues, where applicable. Once a query or a request has been raised, the processing shall halt until after the response to the query has been received. If no response to the query or request has been received within six months the application will be rejected..