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Teriaqi for Regulatory / Services / Medical Device Importation License (MDIL)

Medical Device Importation License (MDIL)

Medical Device Importation License (MDIL) Issuance for Specific Purposes

The purpose of this document is to define and clarify requirements for importing and clearing shipments of medical devices/supplies. This document applies to medical devices, supplies and associated accessories intended for import for private use.

Requirements

Below are several important aspects to take into account:

  • The MDIL for specific purposes is typically requested when an importer has specialized requirements for the import of specific medical devices or equipment that may not fall within standard licensing categories. This license allows the import of medical devices for specific purposes, such as research, clinical trials, or other specialized healthcare initiatives
  • The application submitted to the Saudi Food and Drug Authority must include comprehensive details including: the intended purpose of use and the type and quantity of medical devices to be imported.
  • Importers must prove that the medical devices to be imported meet the required safety and quality standards, even if the purpose of the import is for specific purposes.
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