Medical Device Establishment License (MDEL), Medical Device Importation License (MDIL)
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.
The service timeline varies depending on the type of medical device and imported medical products.
Centennial Medical Establishment
Elipse Health Limited (United Kingdom)
ALMADAR MEDICAL
Allengers
KANEKA PHARMA EUROPE NV
PMLS Upstream Marketing Department of Mindray
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
NingboSoundway Medical Appliances Co , Ltd
Centennial Medical Establishment
Elipse Health Limited (United Kingdom)
ALMADAR MEDICAL
Allengers
KANEKA PHARMA EUROPE NV
PMLS Upstream Marketing Department of Mindray
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
NingboSoundway Medical Appliances Co , Ltd
Centennial Medical Establishment
Elipse Health Limited (United Kingdom)
ALMADAR MEDICAL
Allengers
KANEKA PHARMA EUROPE NV
PMLS Upstream Marketing Department of Mindray
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
NingboSoundway Medical Appliances Co , Ltd
Centennial Medical Establishment
Elipse Health Limited (United Kingdom)
ALMADAR MEDICAL
Allengers
KANEKA PHARMA EUROPE NV
PMLS Upstream Marketing Department of Mindray
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
NingboSoundway Medical Appliances Co , Ltd