Medical Device Establishment License (MDEL) & Importation License (MDIL) in Saudi Arabia

What Is a Medical Device Establishment License (MDEL)?

Medical Device Establishment License (MDEL) authorizes a company to operate facilities for the local manufacturing, storage, importation, and distribution of medical devices in Saudi Arabia. Any entity operating a medical device establishment in the Kingdom must obtain an MDEL from the Saudi FDA (SFDA).

What Is a Medical Device Importation License (MDIL)?

Medical Device Importation License (MDIL) is the Saudi FDA licensing system for establishments that import medical devices into Saudi Arabia (KSA). The importation license must be obtained before each shipment and is applied for through the importer/distributor account. An MDIL is required for IVDs, Non-Medical IVDs, chemicals, distillation products, gases, demo units, and products for research and educational use.

How Bio-Standards Helps You Secure Your MDEL and MDIL License:

• Providing expert regulatory guidance tailored to Saudi FDA MDEL and MDIL requirements.

• Preparing accurate, complete documentation for your MDEL and MDIL applications.

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

• Managing all communication with the Saudi FDA regarding MDEL and MDIL inquiries.

• Ensuring full compliance with MDEL and MDIL regulations for successful licensing.

MDEL and MDIL licensing works hand-in-hand with compliant warehousing and logistics and importation and customs support, and forms part of our medical device registration services in Saudi Arabia.

Download the MDEL e-book or the MDIL e-book for a step-by-step overview, or contact us to start your application.

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