MDS-REQ versus MDS-G: Hierarchy of Saudi Device Requirements and Guidance

1. Key takeaways

MDS-REQ documents are Requirements — mandatory — and MDS-G documents are Guidance; the two are not equals. The binding constraint runs through three layers: Law (M/54), then the Implementing Regulation (No. 3-29-1443), then MDS-REQ. MDS-G explains how to execute and is not an independent source of obligation. The citation order must always be law, implementing regulation, REQ, G, and every response should close its argument in that order. One detail where manufacturers stumble: Annex (15) of MDS-REQ1 V6.0 has been expressly superseded by MDS-G028 V1.0 / 3 May 2026 and no longer applies — proof that where SFDA has stated a replacement, new guidance can override an old REQ annex. The test is not the prefix REQ or G, but the effective date and SFDA’s express statement of replacement. GRZAN most often sees two errors in packages from Chinese companies: treating MDS-G as negotiable, or carrying a superseded MDS-REQ annex into the conformity matrix — the first leaves a response without mandatory support, the second is itself a ground for rejection.

• Binding force runs Law (M/54), Implementing Regulation (No. 3-29-1443), MDS-REQ; MDS-G only explains execution.
• Annex (15) of MDS-REQ1 V6.0 has been expressly replaced by MDS-G028 V1.0, dated 3 May 2026, and must no longer be cited.
• MDS-REQ1 V6.0 (19 December 2021) carries Article 4 with Bundling and Annexes (1) to (11).
• MDS-REQ 11 V2.0 (23 March 2023) sets reporting deadlines of 2, 10 and 30 days and investigation deadlines of 15, 30 and 60 days.
• Whether guidance binds is judged by invocation from a superior document and a stated legislative basis, not by the prefix.

2. Legal basis

The table sets out the key MDS-REQ and MDS-G documents, their serial numbers, dates and the provisions that matter when assembling a submission.

3. Expert insights

Binding force is decided by invocation from a superior document, not by the prefix

The difference between MDS-REQ and MDS-G lies not in the name but in whether the document is authorised by law or by the Implementing Regulation. MDS-G028 V1.0 lists M/54 Articles (1), (3) and (8) and Implementing Regulation Articles 3.1, 10/7 and 10/8 in its legislative basis, and invokes MDS-REQ1 Article 4; its rules that a single application may contain at most 5 technical files and no more than 50 devices therefore carry a complete chain of binding force. By contrast, although the classification rules of MDS-G008 are likewise guidance, MDS-G030 requires in application requirement 1 that the correct risk class of each device be determined per the MDS-G008 rules, pulling the guidance into the mandatory preconditions of the reliance pathway. GRZAN’s test is practical: check whether the first page lists a legislative basis; if it invokes the law or the Implementing Regulation, treat it as mandatory. Purely explanatory content may serve as argumentative support but cannot alone ground a defence against a rejection.

The practical impact on Chinese manufacturers: version control fails more often than content understanding

SFDA revises these documents frequently, and the version number and date are bound into the serial number — MDS-REQ1 is MDS-REQ-001-V6/211219 and MDS-G028 is MDS-G-028-V1/260503. The typical way Chinese companies stumble is writing the technical file from a PDF downloaded a year earlier and citing a superseded annex in the response. At least one replacement is explicit: MDS-REQ1 Annex (15) has been replaced by MDS-G028, and MDS-REQ1 V6.0 now carries 11 current annexes (Annexes 1 to 11). The recommended practice is a list of cited document versions on the cover page of every technical file, recording the short name, version number, version date and serial number, re-checked before each submission. This step costs almost nothing and screens out a meaningful share of deficiency letters. Another easily missed situation is the same content in both a REQ and a G document: Bundling appears in MDS-REQ1 Article 4 and is systematically rewritten in MDS-G028 V1.0. There the latter governs, and the replacement should be noted explicitly in the conformity matrix so the reviewer does not check against the old annex and raise a correction request.

Comparison with the EU MDR, the US FDA and China’s NMPA

EU MDCG guidance is purely interpretive and manufacturers may propose alternatives; US FDA guidance is expressly non-binding and companies may satisfy requirements by other means; China’s technical guiding principles are likewise recommendatory. Saudi Arabia carved the Requirements into the MDS-REQ series with binding force — in substance splitting out the requirements that in the EU system sit inside the MDR annexes. The benefit is fast updating (MDS-REQ 7 on UDI has reached V4.0, MDS-REQ 11 on PMS has reached V2.0); the cost is continuous version tracking. Another Saudi feature is the density of cross-references: MDS-G030 requires classification per MDS-G008 and bundling per MDS-G028, and MDS-G011 requires the QMS to follow MDS-REQ9 and MDS-REQ10. This mesh means reading a single document always leaves blind spots. A final difference in document logic: Chinese guiding principles are issued by product family, one document per category, whereas the Saudi series is split by function — classification, bundling, UDI, post-market surveillance and inspection each have their own document. Functional splitting means updates never interfere, but the price is that any submission requires four or five documents cross-checked at once.

The actual division of labour between the two families is analysed at https://www.grzan.cn/regulations/saudi/mds-g028-bundling-family-and-system-28 , and the application of the classification guidance at https://www.grzan.cn/regulations/saudi/mds-g008-classification-rules-07 .

4. Practical recommendations

• Place a list of cited document versions on the cover page of each technical file, registering the short name, version number, version date and serial number (for example, MDS-REQ-001-V6/211219).
• Fix the citation order as M/54, then Implementing Regulation (3-29-1443), then MDS-REQ, then MDS-G; deficiency responses must not skip the superior documents to cite guidance directly.
• Re-check document versions on the SFDA website quarterly; MDS-REQ1 Annex (15) has been removed from the citation list and MDS-G028 V1.0 cited instead.
• To judge whether an MDS-G binds, check whether its first page states a legislative basis invoking the law or the Implementing Regulation.
• For documents such as MDS-G008 whose version has not been officially corroborated, download the current version from the SFDA website and verify before use (practical estimate).
• Set up a cross-reference check: classification is checked against MDS-G008; multiple devices in one application against MDS-G028; manufacturing and exemptions against MDS-G011 and MDS-REQ5.
• When answering SFDA queries, write the argument along the three-level chain and attach first-page scans of the cited documents so the versions can be verified.

5. Verification checklist

• □ Versions and version dates of all cited MDS-REQ and MDS-G documents confirmed current
• □ Version list established on the technical file cover page and kept updated
• □ Citation order follows law, implementing regulation, REQ, G
• □ MDS-REQ1 Annex (15) removed from the citation list, MDS-G028 V1.0 cited instead
• □ Mapping between MDS-REQ1 V6.0 Annexes (1) to (11) and the project deliverables re-checked
• □ MDS-G008 current version downloaded and verified (practical estimate)
• □ Cross-reference check table covers classification, bundling, manufacturing and exemptions
• □ Deficiency response template includes the three-level chain wording

Regulatory information verified as of 29 October 2026.

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 manages SFDA medical device marketing authorisations and Saudi Authorized Representative arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com