Saudi 2026 Regulatory Updates: MDS-G030, MDS-G028 and Classification Guidance

1. Key takeaways

From late 2025 into 2026, the SFDA landed three key changes within twelve months: MDS-G030, the SFDA Reliance Approach for Medical Device, V1.0 / 2026-09-09, which for the first time systematically recognises existing approvals from 6 RRAs and compresses review to 35-60 working days; MDS-G028, the Guidance on Bundling Criteria for Medical Devices within a Single MDMA Application, V1.0 / 2026-05-03, which replaces Annex (15) of MDS-REQ1 and elevates bundling from annex-level rules to a standalone guideline; and the updated product classification guidance, which consolidates classification decisions into the e-GHAD platform, grants each decision a validity of 1 year, and allows appeals against objections within 30 days (a practical estimate; current SFDA announcements prevail). Together the three point to one route: the SFDA is shifting from reviewing every file independently towards a model of risk stratification plus international reliance.

• MDS-G030 V1.0 (2026-09-09): reliance on 6 RRAs, review in 35-60 working days.
• MDS-G028 V1.0 (2026-05-03): bundling elevated to a standalone guideline.
• Classification decisions consolidated on e-GHAD: 1-year validity, 30-day appeal (practical estimate).
• Five exclusions from reliance, including FDA 510(k) and SaMD with AIeMD.
• Bundling caps: 5 technical files and 50 devices per application.

2. Legal basis

The three 2026 instruments are anchored in the reliance guideline, the bundling guideline and the e-GHAD classification update, read against the parent law and the implementing regulation; the classification dates are a practical estimate pending verification.

3. Expert insights

1. The three instruments are not parallel lines but three facets of one regulatory logic. Read side by side, they form a closed loop: classification decisions answer what risk class a product belongs to; bundling criteria answer which products may share one application; the reliance pathway answers how much of an application the SFDA must assess itself. That the SFDA institutionalised all three in the same year shows its goal is not faster processing at a single step but concentrating limited review capacity on the products that genuinely need local judgement: high-risk, high-novelty categories without international reference points. For Chinese manufacturers holding mature international approvals, this is a window; for those holding only Chinese local registrations without RRA approvals, the window has not opened.

2. The exclusion list of the reliance pathway marks the reserved zone of regulatory sovereignty. The five exclusions of MDS-G030 deserve a line-by-line reading: the self-registration pathway, the equivalence pathway against a predicate device (which directly means FDA 510(k) does not fall into the reliance pathway), custom-made devices, products with post-market safety issues, and SaMD with AIeMD. The first two exclude routes lacking substantive third-party assessment; the third excludes products that cannot be evaluated in a standardised way; the fourth excludes products already acted upon by another regulator; the fifth excludes fields of high novelty and complexity. The logic is consistent: what the SFDA relies on is the substantive technical assessment already performed by other mature regulators, not self-declaration or equivalence arguments. The SFDA also accepts MDSAP certificates and audit reports as QMS evidence.

3. The tightening of bundling criteria turns submission strategy into a compliance capability. MDS-G028 elevates bundling from Annex (15) of MDS-REQ1 to a standalone guideline and makes several substantive tightenings: surgical devices no longer need a shared intended use and are bundled by same function; dental devices are grouped into 11 specialty areas; device systems must have technical files proving the connections between components, replacing the old system-name practice; procedure packs must submit a component list letter; IVD introduces seven groupings requiring the same detection principle; and Class A laboratory general consumables receive an exemption. Caps of 5 technical files and 50 devices per application are also set. These rules turn bundling from a marketing-level product portfolio into a compliance judgement supported by technical files, and a wrong bundling logic leads directly to GHAD rejection.

4. Electronic classification raises the qualification risk for borderline products. The classification update requires that decisions must be obtained via e-GHAD, each valid for 1 year, with appeals within 30 days (a practical estimate, subject to current SFDA announcements). A one-year validity means classification needs periodic re-review and is no longer a one-off determination valid indefinitely; and the clause that products claiming medicinal effects or ingredient levels above specified limits may be reclassified as drugs or health products raises the qualification risk for drug-combination devices, efficacy-type dressings and some home-use products. Classification in turn decides the MDMA route, the fee tier and the PSUR cycle, so classification is a compliance state requiring continuous maintenance, not a one-off pre-application step.

Further threads in this series: reliance pathway overview https://www.grzan.cn/regulations/saudi/sfda-reliance-pathway-mds-g030-12 ; the 6 RRAs and technical sameness https://www.grzan.cn/regulations/saudi/reliance-pathway-eligibility-and-rra-13 ; why 510(k) is excluded https://www.grzan.cn/regulations/saudi/why-fda-510k-excluded-from-reliance-14 ; MDSAP as QMS evidence https://www.grzan.cn/regulations/saudi/mdsap-certificate-as-qms-evidence-15 ; SaMD and AIeMD exclusion https://www.grzan.cn/regulations/saudi/samd-and-aiemd-reliance-exclusion-16 ; bundling, families and systems https://www.grzan.cn/regulations/saudi/mds-g028-bundling-family-and-system-28 ; bundling, procedure packs, dental and IVD https://www.grzan.cn/regulations/saudi/mds-g028-bundling-procedure-pack-and-ivd-29 ; the A/B/C/D class logic https://www.grzan.cn/regulations/saudi/sfda-risk-classification-abcd-06 ; MDS-G008 classification rules https://www.grzan.cn/regulations/saudi/mds-g008-classification-rules-07 .

4. Practical recommendations

• Run a three-instrument health check per product line: judge the classification status, the bundling scheme and the reliance eligibility item by item.
• For products holding TGA, Health Canada, EEA, PMDA, MHRA or non-equivalence FDA approvals, evaluate the reliance pathway first and re-plan the market timetable on 35-60 working days.
• For products whose main entry evidence is FDA 510(k) or self-declaration, prepare under the conventional MDMA route and do not cut technical file investment because of reliance news.
• Where an MDSAP certificate exists, include the certificate and audit reports in the application pack in place of repeated quality system assessment.
• Restructure product families under MDS-G028: surgical devices grouped by function, dental by specialty area, systems with technical files proving connections, procedure packs with component list letters.
• Keep each application strictly within 5 technical files and 50 devices; split the application beyond that.
• Put e-GHAD classification decisions on the annual review calendar and back-schedule reviews against the 1-year validity; file appeals within 30 days (the related dates are a practical estimate, subject to current SFDA announcements).
• For products claiming medicinal effects or sitting near ingredient limits, run a border qualification assessment first to avoid reclassification as a drug.

5. Verification checklist

• □ Current texts of MDS-G030 V1.0 (2026-09-09) and MDS-G028 V1.0 (2026-05-03) have been downloaded
• □ Classification status of every product line has been verified on e-GHAD (validity and appeal periods are a practical estimate)
• □ Bundling schemes of product families have been re-planned under MDS-G028
• □ Technical file count and device count per application have been checked against the caps
• □ The component list letter template for procedure packs is ready
• □ Reliance eligibility has been self-assessed against the 4 general criteria
• □ RRA approval evidence and the Reliance Form have been prepared
• □ The MDSAP certificate and audit reports are in the application pack
• □ 510(k)-type products have been re-planned under the conventional route
• □ The new instrument timetable has been merged into the annual compliance calendar

Regulatory information verified as of October 29, 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 adverse event reporting and recall coordination with the SFDA National Center, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com