The Medical Device Establishment License (MDEL) is a regulatory requirement established by the Saudi Food and Drug Authority (SFDA) to ensure the safety, efficacy, and quality of medical devices distributed or manufactured in Saudi Arabia. It is a critical step in the regulatory process to monitor and control the medical device market within the country.
The MDEL applies to any establishment involved in the import, distribution, or manufacturing of medical devices. It also applies to authorized representatives involved in importation or distribution activities in Saudi Arabia.
To obtain a Medical Device Establishment License (MDEL) in Saudi Arabia, establishments typically need to fulfill several key
requirements:
▪ The establishment national registry number assigned to it by the SFDA after registering with the MDNR.
▪ Quality Management System (QMS): ISO 13485
▪ Good Distribution Practices (GDP): For distributors, adherence to Good Distribution Practices is crucial. This includes proper
storage, handling, and distribution of medical devices to maintain their integrity and safety.
▪ Good Manufacturing Practices (GMP): For manufacturers, compliance with Good Manufacturing Practices is essential to
ensure the production of safe and effective medical devices.
▪ Technical Documentation.
▪ Inspections and Audits: Be prepared for periodic inspections and audits by the SFDA to ensure ongoing compliance.
▪ Labeling and Packaging: Ensure that the labeling and packaging of medical devices conform to the SFDA’s regulations
| Services | Application Fee (SFDA Fees) |
|---|---|
Medical Device Establishment License MDEL |
SAR 5,000 to SAR 25,000 |
Required Documents
10 working days
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Taryaki includes a cadre of experienced experts with specialized experience and knowledge in regulatory affairs and registration of medical devices and laboratory devices with the Saudi Food and Drug Authority, headquartered in Riyadh, Kingdom of Saudi Arabia.
