Certification Introduction

Market access for medical devices in Saudi Arabia is uniformly regulated by the Saudi Food and Drug Authority (SFDA). In accordance with Saudi medical device regulatory rules, products are divided into four categories A, B, C and D based on product risk, and differentiated registration management is implemented.

Laws and Regulations

Core current regulations include: The Law of Medical Devices and Supplies; Implementing Regulation of the Medical Devices Law; MDS series (technical specifications and guidelines issued by the SFDA Department of Medical Devices): such as MDS-REQ, MDS-G; All registration applications must be submitted through SFDA's official GHAD online electronic service system. For specific classification requirements, review rules and process adjustments, please refer to the latest announcements on SFDA's official website.

Technical Requirements

For Saudi registration, medical devices are classified from low to high risk into four categories A, B, C and D, and different categories correspond to differentiated compliance and technical control requirements. Overseas manufacturers must hold a valid ISO 13485 quality management system certification (with IAF accreditation mark) to meet Saudi regulatory requirements for quality control throughout the entire product life cycle. Relevant test reports for medical devices must be issued by ILAC-accredited laboratories. Submitted certification documents are required to be in English or Arabic. If the product is intended for use by non-medical professionals, Arabic versions of the instruction manual, labels and promotional materials must be provided. Relevant performance tests shall fully consider the climatic conditions of Saudi Arabia to ensure that the validity period and performance data can cover extreme use scenarios above 50°C. If the medical device contains a wireless transmitting module (such as Bluetooth/Wi-Fi), in addition to meeting SFDA regulations, it must also obtain radio equipment type approval from CST. A post-market adverse event monitoring and feedback mechanism must be established, regular safety update reports shall be submitted as required by SFDA, and post-market compliance obligations shall be continuously fulfilled.

Certification Process

Confirm product risk classification (Class A/B/C/D), and clarify the corresponding market access path and compliance requirements.

Appoint a local authorized representative that meets the requirements of Saudi regulations, as the legal liaison between overseas manufacturers and SFDA.

Prepare a complete set of application materials in accordance with Saudi regulatory requirements, and complete the translation, notarization and double authentication process.

For Class A low-risk products, the local authorized representative submits a Listing filing application through the GHAD system, and market access is granted after passing the formal review.

For some Class A products requiring registration and medium-to-high risk Class B/C/D products, submit the medical device registration application through the GHAD system. SFDA conducts Technical File Assessment (TFA) for products requiring registration, requests supplementary materials or on-site inspection when necessary, and the Medical Device Marketing Authorization (MDMA) certificate is obtained after review and approval.

After the product is launched, it is necessary to continuously fulfill regulatory obligations such as adverse event reporting, annual compliance update, and post-market surveillance.

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