MDS-G028 Bundling in Saudi Arabia: Procedure Packs, IVD Grouping, Class A Exemption

1. Key takeaways

The second half of MDS-G028 V1.0 / 2026-05-03 (MDS-G-028-V1/260503) covers three routes. Procedure packs: 5 conditions plus 4 mandatory attached requirements, same-manufacturer binding only main packs, and a 6-field component list letter required. Dental devices: 11 specialties, overlaps resolved by the label intended use. IVDs: the legal manufacturer must share an identical name and address, the same risk class, intended use and testing principle, within one of 7 groupings; where the same clinical and performance evaluation data apply to all cited products, the submission counts as 1 TF, capped at 5 TFs and 50 items. Class A IVDs in specified categories enjoy a separate exemption.

• The pack same-manufacturer condition covers only main packs, not components.
• The 6-field component list letter pins responsibility per component manufacturer.
• For IVDs, manufacturer name and address must both match, as must the testing principle.
• IVDs fall into 7 groupings; caps are 5 TFs and 50 items.
• Class A IVDs in listed categories are exempt from the grouping and TF caps.

2. Legal basis

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

3. Expert insights

Two faces of the same-manufacturer rule: loosened for packs, tightened for IVDs. Within one guidance, the condition appears at two strengths. The pack section states that it applies only to the main packs, not the components inside, consistent with Annex 1: a pack may or may not share one manufacturer (typically surgical instruments, dressings, or materials). The IVD section runs the other way, demanding an identical name and address, excluding different legal entities in one group and even the same entity at different addresses.

The contrast is the SFDA allocating bundling freedom by risk controllability. A pack concentrates risk at the pack level: components hold their own approvals and traceable manufacturers, so a responsible main-pack entity suffices. An IVD concentrates risk at the reagent level: same-brand data from different sites cannot be accepted for each other, so the rule tightens to a double match.

The six fields of the component list letter pin responsibility to each component manufacturer. Among the 4 mandatory attached requirements, the most concrete is the fourth: a component list letter carrying the component name, risk class per SFDA classification, classification rationale, any existing approval (number if so), intended use or brief description, and legal manufacturer name and address.

The other three: technical documents for the pack and every component; each component’s contents label in the labeling section; approvals with each component manufacturer’s consent letter, ensuring documents are available upon SFDA request. Two boundaries: a component for separate sale requires its own application; a pack containing a medicinal product requires the SFDA drug-sector marketing authorization.

Dental classification in practice: read the label, not the sales pitch. The 11 specialties, illustrative and non-exhaustive: general dentistry, restorative dentistry, oral surgery, dental implantology, orthodontics, periodontics, endodontics, prosthodontics, pediatric dentistry, prevention and oral hygiene, laboratory or clinic. Three rules: oral surgery and implantology overlap on some 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; non-patient-contact laboratory and auxiliary devices are not therapeutic devices.

The common thread: label and IFU wording is the only basis; catalog and sales explanations do not count. Family and system boundaries: https://www.grzan.cn/regulations/saudi/mds-g028-bundling-family-and-system-28.

The seven IVD groupings and the linkage with MDS-G030 eligibility. The 7 groupings: blood group typing (ABO, Rh, Kell, Kidd, and Duffy systems); histocompatibility typing (HLA A, B, DR); cancer and non-malignant tumor markers (excluding human genetic testing); human genetic testing; infectious disease markers and immune status (prenatal screening, transfusion and transplantation suitability, sexually transmitted pathogens, infection load and staging, pathogen culture); non-infectious pathological or physiological markers (excluding human genetic testing; diseases vs states and treatments); and quality controls without quantitative or qualitative assignment.

Grouping decides whether the reliance pathway stays open. MDS-G030 requires multi-device applications to comply with MDS-G028, while the reliance pathway requires technical identity with the RRA-approved device. Once the grouping crosses a testing principle or intended use, one RRA approval cannot cover the whole group, and the SFDA may require a split or supplementary information. Overlay the grouping boundaries against the RRA approval coverage; see https://www.grzan.cn/regulations/saudi/sfda-reliance-pathway-mds-g030-12.

The Class A exemption is the most easily missed subtraction of this version. IVDs in the listed categories, Class A only and not blood specimen collection devices, laboratory mechanical devices, or automated power systems, are exempt from item C (intended use, testing principle, grouping) and item D-1 (the 5-TF cap): specimen containers; dyes and stains; culture media, broths, and their supplements; general-purpose reagents (cytology preservatives, decalcifiers, fixatives, tissue processing reagents, isotonic solutions, pH buffers, and further listed media); tissue processing equipment (collection containers, embedding cassettes, cover glasses, slides, filters, tubes); and cell and tissue culture products and equipment (dishes, flasks, rollers, roller bottles, tubes, rotators, cell culture apparatus).

For Chinese makers of pathology and laboratory consumables, huge model counts and low unit prices make item-by-item application spiral in cost and time; with it, one application covers multiple categories unrestricted. Technical documentation and performance evaluation: https://www.grzan.cn/regulations/saudi/ivd-performance-evaluation-annex7-27.

4. Practical recommendations

• For pack projects, build a component ledger first, filling all 6 component list letter fields; missing fields risk rejection.
• Obtain each component manufacturer’s consent letter confirming technical documents are available upon SFDA request.
• Where a component is sold separately, plan an independent MDMA application.
• For packs containing a medicinal product, confirm its marketing authorization with the SFDA drug sector.
• Provide labeling component by component; a main-pack label alone is unacceptable.
• For dental projects, assign the 11 specialties from each model’s label; overlaps follow the label.
• For IVD projects, verify name and address are fully identical first; split differently addressed sites into separate applications.
• Record the testing-principle determination in writing and cross-check against RRA approval coverage.
• Class A makers of general-purpose reagents and consumables should claim the exemption, stating the relied-upon category.
• Sequence milestones against the three major new rules: https://www.grzan.cn/regulations/saudi/saudi-2026-regulatory-update-review-49.

5. Verification checklist

• □ Using MDS-G028 V1.0 / 2026-05-03, no misuse of Annex (15)
• □ Pack same-manufacturer condition binds only main packs; components may come from different manufacturers
• □ All 6 component list letter fields complete
• □ Technical documents submitted for pack and every component
• □ Labeling provides each component’s contents label
• □ Every component manufacturer’s consent letter on file
• □ Medicinal-product packs hold the SFDA drug-sector marketing authorization; separately sold components filed separately
• □ IVD name and address fully identical, testing principle identical, within one of the 7 groupings
• □ IVD TF count ≤ 5, item count ≤ 50 including accessories; Class A exemption tested
• □ Dental devices classified across the 11 specialties by label and IFU

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