After a device receives its marketing authorization, the manufacturer may need to add new models or sizes, update manufacturer details, or change labeling or manufacturing sites. In many cases this can be done through a variation request on the existing registration instead of starting over.
Adding models within the same product family, changing the manufacturer name or address, updating certificates after renewal, changing labels or instructions for use, and changing the Authorized Representative.
It depends on the size of the change and its effect on the device's safety and performance. Administrative changes are treated differently from changes to design or intended use, which may require a deeper technical review or a new application.
A clear description of the change, updated documents such as certificates and labels, and evidence that new models belong to the same registered product family.
We assess the change, identify the right route, prepare the request on Ghad and follow it through to approval.
Get in touch and we'll help with your specific case.
