Medical Device Technical Documentation in Saudi Arabia: MDS-REQ 1 Annex (3) Explained

1. Key takeaways

Medical device technical documentation in Saudi Arabia, known as the Technical File or TF, is governed by MDS-REQ 1 Annex (3). Its skeleton is closely aligned with EU MDR technical documentation, but dossier granularity and the presentation of evidence are decided separately by the SFDA. Devices in the lowest risk class that do not fall within any excluded situation may submit against a 6-item simplified document list. At the same time, the SFDA reserves the right to request the full technical documentation at any time and requires submission within 10 days of the request. Item 5 of Annex (3) is the risk management file, which connects directly to ISO 14971. The GRZAN position is that in Saudi Arabia the technical file is a living dossier that can be retrieved at any moment, not a static archive sealed once at submission.

• Annex (3) of MDS-REQ 1 sets the mandatory structure and content of the device technical file.
• Low-risk devices may submit only the 6-item simplified list, subject to five exclusions.
• The SFDA may request the complete technical documentation at any time, with a 10-day submission window.
• Item 5 of Annex (3) is the risk management file, aligned with ISO 14971.
• Annex (1), Annex (6), and Annex (10) supply the EPSP, clinical evaluation and PMCF, and e-IFU layers respectively.

2. Legal basis

The table below maps each requirement to its source instrument, document number, publication date, clause, and the key point of the original text. Regulatory information verified as of October 29, 2026.

3. Expert insights

Shared origin does not mean shared structure: misalignment remains after aligning with EU technical documentation. The Saudi device technical file and the EU MDR technical documentation are closely aligned in their pillars: device description and specification, information supplied by the manufacturer, conformity to the essential principles, risk management, and post-market surveillance plans and reports. Shared origin settles what the documents are called; it does not settle how deep the documents must go. The SFDA makes the technical file mandatory through Annex (3) while issuing a separate 6-item simplified list for low-risk devices through Article (4) and the Notes, allocating dossier depth by risk class rather than applying one depth to all.

The practical consequence for Chinese manufacturers is that renaming a CE technical file and uploading it directly rarely fails on missing chapters; it fails because the evidence granularity inside each chapter does not match the retrieval path of SFDA reviewers. The same risk analysis report may be accepted as a whole volume in Europe yet need re-anchoring clause by clause against individual essential principles in Saudi Arabia.

The six-item simplified list is a double-edged sword. The 6-item simplified list for low-risk devices — device description and specification, information supplied by the manufacturer, the Essential Principles Checklist, evidence of conformity, the risk management file, and post-market surveillance plans and reports — lowers the cost of building a dossier considerably. But the same rule attaches the 10-day clause: the SFDA may request the full technical documentation at any time, and it must be submitted within 10 days of the request.

The real constraint of this rule is not the number of days but that it transfers the choice of whether to submit from the applicant to the reviewer. A company that prepared only the 6 items at submission will find 10 days rarely enough to rebuild the complete dossier from zero once cross-border retrieval, stamping, and translation are involved. The GRZAN working convention is to use the simplified list for submission and the complete dossier for readiness, maintaining both in parallel.

Dossier granularity determines the number of deficiency rounds. GHAD is the single MDMA submission gateway, with the technical file attached electronically to the application. What reviewers search for in the system is where the evidence of conformity for a given essential principle sits, not whether the file looks complete as a whole. The table of contents should therefore map onto the clause numbers of the Essential Principles of Safety and Performance, so that every principle can be located against a specific verification report, test record, or design output.

When GRZAN restructures a technical file, every row of the EPSP checklist must carry a clickable evidence anchor pointing to a specific document and page within the same dossier. In Europe this is a bonus; in Saudi Arabia it is necessary to reduce deficiency rounds. For how to write the EPSP checklist itself, see https://www.grzan.cn/regulations/saudi/essential-principles-of-safety-and-performance-24 ; for where the risk management file sits within Annex (3), see https://www.grzan.cn/regulations/saudi/risk-management-file-iso-14971-25.

4. Practical recommendations

• Have the registration lead fix the risk class before fixing the dossier depth: a wrong class decision distorts the workload, and the classification logic is set out in MDS-REQ1 Annex (5) and MDS-G008.
• Build a two-way mapping table between EPSP clause numbers and evidence files as the front index of the technical file, with no row left without evidence.
• Even when using the 6-item simplified list, maintain a complete technical documentation set in parallel, with retrieval contacts designated for both the in-country responsible person and the foreign manufacturer.
• Keep the complete technical documentation exportable at any time, avoiding dependence on a single local server or personal computer; 10 calendar days is the limit.
• The information supplied by the manufacturer must include the label and instructions for use, with language layered by user type; see https://www.grzan.cn/regulations/saudi/arabic-labeling-and-ifu-requirements-30.
• Keep the version numbers of the technical documentation consistent with the models, brand names, and UDI-DI data declared in GHAD, avoiding field conflicts with Saudi-DI.
• If the reliance pathway is intended, the technical file must additionally demonstrate identity in design, manufacturing process, and intended use with the device approved by a recognized regulatory authority; see https://www.grzan.cn/regulations/saudi/reliance-pathway-eligibility-and-rra-13.
• Before finalizing the file, have the GRZAN regulatory team run a clause-level comparison against the current SFDA version, focusing on whether Annex (3) has been upgraded.

5. Verification checklist

• □ The SFDA risk class of the product has been confirmed, and the choice between the 6-item simplified list and the full technical file follows from it
• □ The five excluded situations, IVD, sterile, measuring function, reusable surgical instruments, and innovative products, have been ruled out
• □ The technical file table of contents maps onto the EPSP clause numbers with no empty rows
• □ The risk management file is in place and corresponds to item 5 of Annex (3)
• □ Post-market surveillance plans and reports are included and connected to the reporting channels of MDS-REQ 11
• □ The complete technical documentation has been backed up and can be produced within the 10-day window after a retrieval notice
• □ File version numbers, models, and brand names match the fields in GHAD and Saudi-DI
• □ The current version of MDS-REQ 1 and any upgrade of Annex (3) have been checked on www.sfda.gov.sa (a mandatory check among the practical estimate items)

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Saudi Arabian market. Our team prepares SFDA-compliant STAR dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com