Medical Device Establishment License (MDEL) authorizes a company to establish facilities for the local manufacturers, storage, and importer & distribution of medical devices. Any entity operating a medical device establishment in Saudi Arabia must obtain an MDEL from the Saudi FDA.
Medical Device Importation License (MDIL) is a Licensing system for the establishments involved in the importation of medical devices to KSA. The Importation License shall be obtained before the shipment and it needs to be applied through the importer/distributor account. MDIL is required for IVDs, Non-Medical IVDs, Chemicals, Distillation, Gases, Demos, Research and Educational use products.
Medical Device Establishment License (MDEL) authorizes a company to establish facilities for the local manufacturers, storage, and importer & distribution of medical devices. Any entity operating a medical device establishment in Saudi Arabia must obtain an MDEL from the Saudi FDA.
Medical Device Importation License (MDIL) is a Licensing system for the establishments involved in the importation of medical devices to KSA. The Importation License shall be obtained before the shipment and it needs to be applied through the importer/distributor account. MDIL is required for IVDs, Non-Medical IVDs, Chemicals, Distillation, Gases, Demos, Research and Educational use products.