Saudi SFDA Introduces Medical Device Reliance Pathway: MDS-G30 Regulatory Update

The Saudi Food and Drug Authority (SFDA) published Version 1.0 of SFDA Reliance Approach for Medical Device (MDS-G30) on September 10, 2026. The guidance introduces a reliance route for eligible Medical Device Marketing Authorization (MDMA) applications and explains how prior approvals from recognized regulatory authorities may support a more efficient SFDA review.

The pathway is particularly relevant to international medical device manufacturers that already hold an approval in a recognized jurisdiction and plan to enter the Saudi market. Reliance can reduce duplicated assessment, but it does not replace SFDA decision-making or Saudi-specific regulatory requirements.

Which regulatory approvals can support reliance?

MDS-G30 identifies approvals from the following recognized regulatory authorities and jurisdictions:

• Australia’s Therapeutic Goods Administration (TGA).
• Health Canada.
• National competent authorities in the European Union and European Economic Area.
• Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
• The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).
• The US Food and Drug Administration (FDA).

SFDA may update this list periodically, including by adding jurisdictions represented on the International Medical Device Regulators Forum Management Committee.

General eligibility criteria

An MDMA application must satisfy three central conditions to be considered for the reliance pathway:

1. The device must hold a valid marketing authorization or approval from at least one recognized regulatory authority.
2. The device submitted to SFDA must have the same technical characteristics as the authorized device, including its design, manufacturing process, and intended use.
3. The device must comply with applicable Saudi requirements.

Saudi-specific requirements can include electrical power and building-code considerations, Arabic labeling and instructions for use, user-interface language, and storage or transportation controls appropriate to local temperature and humidity conditions.

Quality management system evidence

The guidance states that SFDA accepts Medical Device Single Audit Program (MDSAP) certificates and audit reports issued by recognized MDSAP Auditing Organizations as evidence of conformity with quality management system requirements.

Manufacturers should confirm that certificates, audit reports, manufacturing-site information, and the legal-manufacturer details used in the MDMA application remain current and consistent with the reference approval.

Which products or routes may be excluded?

MDS-G30 identifies several exclusions and limitations:

• Products authorized only through manufacturer self-registration or self-declaration without independent assessment.
• Products whose market access was based primarily on equivalence to a predicate device.
• Custom-made medical devices.
• Products subject to significant recalls, suspensions, withdrawals, or regulatory restrictions in a reference jurisdiction.
• Software as a Medical Device and AI-enabled medical devices where intended use, risk, novelty, complexity, or other considerations require a different SFDA assessment.

The existence of a foreign approval therefore does not automatically make a device eligible. The approval route, device identity, regulatory history, and risk profile must be assessed before selecting reliance.

How to apply through the SFDA system

Eligible manufacturers and authorized representatives apply through the SFDA E-Services portal as part of the MDMA process. The main steps are:

1. Create the required SFDA account and obtain an establishment number if one is not already available.
2. Confirm in the MDMA application that the device holds an approval from a recognized regulatory authority.
3. Identify the relevant country and approval title, then upload evidence of each approval.
4. Complete the MDS-G30 Reliance Form and upload it as part of the application.

The Reliance Form must explain why reliance is appropriate, summarize the device’s international regulatory status, and confirm that the Saudi submission covers the same intended purpose, design, specifications, manufacturing information, and labeling as the reference authorization, where applicable.

Applicants must still apply SFDA classification rules under MDS-G008. When multiple devices are included in one MDMA application, the grouping should follow the MDS-G028 bundling criteria. SFDA may also request additional information for novel, complex, or higher-risk technologies, including AI-enabled devices, companion diagnostics, and combination products.

Expected review timeline

MDS-G30 gives a standard reliance-pathway review timeline of 35 to 60 working days for Classes A, B, C, and D, provided that the application is complete and all required documentation has been submitted.

The review may be reduced to approximately 35 working days when SFDA can rely on the prior recognized approval instead of conducting a full independent assessment. This is not an automatic approval timeline: incomplete documentation, eligibility questions, or requests for additional evidence may extend the review.

Post-market surveillance remains essential

The reliance approach also extends to post-market regulatory intelligence. SFDA may consider recalls, field safety corrective actions, field safety notices, adverse-event information, and other actions published by recognized authorities.

Manufacturers and Saudi authorized representatives must therefore maintain effective vigilance, safety communication, change-control, and reporting processes after authorization. A reliance-based MDMA does not reduce the manufacturer’s continuing Saudi post-market obligations.

Practical actions for manufacturers

Before choosing the MDS-G30 route, manufacturers should:

• Verify that the reference approval and authorization route are eligible.
• Confirm that the Saudi device is technically identical to the reference-authorized device.
• Review differences in labeling, IFU, language, electrical, environmental, and supply-chain requirements.
• Align the MDMA application, Reliance Form, certificates, QMS evidence, and reference-market documentation.
• Review global safety history for recalls, restrictions, or unresolved post-market signals.
• Establish the Saudi authorized representative, importer, and establishment arrangements before submission.

How CMS Medtech can support Saudi market access

CMS Medtech supports manufacturers with Saudi regulatory pathway assessment, MDS-G30 eligibility review, SFDA device classification, MDMA dossier readiness, reference-approval comparison, Reliance Form preparation, authorized-representative coordination, labeling and IFU review, and post-market compliance planning.

Early route assessment can determine whether reliance is appropriate or whether a standard SFDA review pathway offers a more defensible submission strategy for the device.

Official SFDA sources

• SFDA Reliance Approach for Medical Device (MDS-G30)
• Official MDS-G30 guidance PDF
• SFDA medical device guidelines

This article provides a general regulatory update and does not constitute product-specific legal or regulatory advice. Eligibility and submission requirements should be confirmed against current SFDA resources and the characteristics of the medical device.