2026

Medical Device Establishment Licensing: Import vs. Distribution vs. Storage

The SFDA issues licenses that allow medical device and supply establishments to operate according to their type and activity. Applications are submitted through Ghad, and processing time and fees vary by establishment type and activity.

Main activities

Import allows devices to be brought into the Kingdom. Distribution allows them to be sold and supplied within the market. Storage covers warehouses that hold the products. There is also the Authorized Representative activity, which represents a foreign manufacturer before the SFDA and has its own requirements.

How to choose

Define what you will actually do: will you import yourself, or buy from a local importer and resell? Do you have your own warehouse, or will you use a licensed third-party warehouse? The answers determine the activities your license needs.

An important note

A license activity that does not match what you actually do is one of the most common reasons import permit and clearance requests are rejected.

How we help

We help you define the right activity, prepare the license file and follow it through. You can also use storage at our licensed medical warehouse instead of setting up your own.

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