Regulations

What is Medical Device Establishment Licensing (MDEL)?

Medical Device Establishment Licensing (MDEL) is a licence issued by the SFDA to establishments that import, distribute or manufacture medical devices in Saudi Arabia.

How it differs from MDMA

MDEL relates to the establishment handling medical devices, while MDMA relates to the product itself. Both are considered when evaluating a supplier.

Reference

The SFDA publishes its licensing requirements and services on its official website, which is the authoritative source for any updates.

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