Do custom-made devices need to be registered in Saudi Arabia?

Belinda Lin

Medical Device RA
Hi friends! I knew before that a custom-made device does not require registration with the SFDA, and an importation license (MDIL) is required per shipment instead. Has this requirement changed?
Recently my client asked us to register our custom-made device in SFDA which is a requirement for the application to Nupco tender, in Parallel to MDIL. If this is true, it means a custom-made device can either obtain an MDMA or an MDIL for importation to Saudi, right?
 
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