MDS-G028 Bundling in Saudi Arabia: Device Families, Surgical Instruments, Dental Devices, Systems

1. Key takeaways

In May 2026 the SFDA issued MDS-G028, the Guidance on Bundling Criteria for Medical Devices within a Single MDMA Application, version V1.0, version date 2026-05-03, document code MDS-G-028-V1/260503, replacing Annex (15) of MDS-REQ1. Families must satisfy 7 conditions simultaneously; surgical instruments are a special case bundled by identical function with 7 named functions; dental devices are a new special case requiring the same specialty, with 11 listed. Systems likewise carry 7 conditions; the sale-by-system-name practice is deleted, and technical documents must prove component connections. All routes share two hard caps: max 5 TFs and 50 devices per application.

• Family bundling requires all 7 conditions to hold; one failure removes the whole group.
• Surgical instruments bundle by identical function across 7 exemplified functions.
• Dental devices bundle by specialty across 11 officially listed specialties.
• Systems must be connected through technical documents, one system per application, highest component risk class governing.
• Hard caps on every route: 5 TFs and 50 devices per application.

2. Legal basis

The table maps the MDS-G028 provisions and their legal foundations. Regulatory information verified as of October 29, 2026.

3. Expert insights

The seven family conditions are conjunctive, not a scoring table. The 7 conditions — same legal manufacturer, intended use, risk class, GMDN code definition where one exists, common physical design, construction materials and manufacturing process, max 5 TFs, ≤ 50 items — must all hold; any single failure removes the group.

Two attached rules: a stand-alone product may not be bundled with its set or kit in the same application, even as a component of that kit — both sales forms require two applications; and a component or accessory that is itself a medical device labeled for use with a specific device is not a single device and follows the system criteria.

Official examples: catheters of multiple lengths and brands, guidewires of different tip shapes, hearing aids differing only in color, bone plates of varied shapes sharing one intended use, and a single-model intraocular lens differing only in diopter can all form a family. A single-chamber and a dual-chamber implantable cardioverter defibrillator can also form a family when the dual-chamber contains all single-chamber functions with identical base software, with specific indications allowed to differ.

Surgical instruments: from identical intended use to identical function, the largest relaxation. Surgical instruments are bundled by identical function, illustrative and non-exhaustive: cutting or incising, retracting, grasping clamping or occluding, dilating or probing, cannulation or drainage, suction injection or infusion, and suturing or ligation. Remaining conditions: same manufacturer, same risk class, common construction materials and manufacturing process, max 5 TFs, ≤ 50 items.

The rationale: a hemostat and a tissue forceps can carry different intended use statements while sharing risk sources in material, edge geometry, surface treatment, and sterilization; the anchor switch acknowledges that risk is determined by construction, not indication. For Chinese surgical instrument exporters, clamps and scissors of one material no longer need separate applications per indication.

Dental devices: 11 specialties and three classification rules. Dental devices are a new special case requiring one specialty. The 11 specialties: general dentistry, restorative dentistry, oral surgery, dental implantology, orthodontics, periodontics, endodontics, prosthodontics, pediatric dentistry, prevention and oral hygiene, dental laboratory or clinic.

Three rules: oral surgery and implantology overlap on certain devices, classified by the label intended use; general or multi-purpose surgical instruments fall into general dentistry unless the IFU restricts them to specific dental procedures; laboratory and auxiliary devices that do not touch the patient are not classified as therapeutic devices. The third rule is the most valuable in practice. Full treatment: https://www.grzan.cn/regulations/saudi/mds-g028-bundling-procedure-pack-and-ivd-29.

Systems: the sale-by-system-name route is deleted; the highest risk class governs. Among the 7 conditions, two are hardest. A device system must be connected through technical documents — labels, IFUs, brochures, catalogs, and clinical evaluation files declaring each component is for use with the system; assembling devices under one brand name no longer works. And one application may contain only one system, with the highest component risk class applying.

Official examples: a hip replacement system of femoral and acetabular components, sizes variable; an electrosurgical generator with forceps, electrodes, electrode holders, cables, and adapter plugs; an endoscopy tower with the camera head as the main device and screens, scopes, and scope-mounted tools as accessories. The highest-class rule decides fees and review depth: a system of a Class B generator and Class A accessories proceeds as Class B; see https://www.grzan.cn/regulations/saudi/sfda-risk-classification-abcd-06.

The linkage between bundling and the reliance pathway: classify first, then test eligibility. Item 2 of the MDS-G030 application requirements: a single application with multiple devices must comply with the MDS-G028 bundling criteria. Bundling is therefore the gate before the reliance pathway: with wrong grouping, even approval from one of the 6 recognized regulatory authorities cannot open the 35–60 working day channel. GRZAN advises fixing grouping first, pathway second, as the first project decision; see https://www.grzan.cn/regulations/saudi/sfda-reliance-pathway-mds-g030-12 and https://www.grzan.cn/regulations/saudi/reliance-pathway-eligibility-and-rra-13.

4. Practical recommendations

• Produce a bundling decision table at project start, testing the six routes — family, surgical instruments, dental devices, system, procedure pack, IVD — one by one, selecting only one.
• Test the 7 family conditions one by one, moving out any device failing one condition for separate filing.
• Never place a stand-alone product in the same application as its set or kit; both sales forms require two MDMA applications.
• Components or accessories labeled for use with a specific device move directly to the system route.
• Group surgical instrument dossiers by the 7 functions, stating at the front of each group the common construction materials and manufacturing process.
• For dental devices, fix the specialty among the 11 first, resolve overlaps by the label intended use, and handle laboratory devices separately.
• For the system route, prepare a connection evidence pack: paragraphs in labels, IFUs, brochures, catalogs, and clinical evaluation files proving component use together, with page numbers.
• Where a system contains components of different risk classes, prepare documents and budget for the highest class overall.
• Re-count TFs and devices before submission, confirming ≤ 5 files and 50 items.
• If the reliance pathway is also intended, answer Yes in GHAD Overview subsection (2.1) to activate (2.1.1), then upload the Reliance Form; see https://www.grzan.cn/regulations/saudi/saudi-2026-regulatory-update-review-49.

5. Verification checklist

• □ Using MDS-G028 V1.0 / 2026-05-03, not the superseded MDS-REQ1 Annex (15)
• □ The 7 family conditions passed item by item, GMDN definition included
• □ No stand-alone product mixed with a kit; combined-use components moved to the system route
• □ Surgical instruments grouped by identical function, categories stated up front
• □ Dental specialties assigned, overlaps resolved by the label intended use
• □ The system carries complete connection evidence; one application contains only 1 system
• □ The system risk class follows the highest class among components
• □ TF count ≤ 5, device count ≤ 50, including accessories
• □ MDS-G028 confirmed current on the SFDA website

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