Medical Device Importation & Distribution License

What is the Medical Device Establishment License (MDEL)?

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.

What is the Medical Device Importation License (MDIL)?

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.‍

REG SOLUTIONS aids in securing MDEL and MDIL licenses by:

• Offering regulatory guidance specific to MDEL and MDIL requirements.

• Assisting with documentation preparation tailored to MDEL and MDIL applications.

• Ensuring timely and accurate submission of MDEL and MDIL license applications.

• Handling communications with authorities regarding MDEL and MDIL inquiries.

• Guaranteeing adherence to MDEL and MDIL regulations for successful licensing.