IVD Technical Documentation in Saudi Arabia: MDS-REQ 1 Annex (4) Requirements

1. Key takeaways

In vitro diagnostic devices (IVDs) entering Saudi Arabia follow MDS-REQ 1 Annex (4), not the Annex (3) that applies to medical devices, with the essential principles checklist switching to Annex (2) instead of Annex (1). Two differences are most often overlooked. First, the simplified document list for low-risk devices explicitly does not apply to IVDs: an IVD cannot submit fewer documents simply because its risk is low. Second, the core of the IVD evidence package rests on two parallel chains, analytical performance and clinical performance, carried together by the Performance Evaluation framework under Annex (7). GRZAN recommends treating IVD technical documentation as a stand-alone dossier system rather than reusing the table of contents of a device technical file.

• IVDs follow MDS-REQ 1 Annex (4); devices follow Annex (3), and the two dossier structures must not be mixed.
• The essential principles checklist for IVDs is Annex (2), not Annex (1).
• The six-item simplified document list for low-risk devices excludes IVDs, so every IVD submits under the full Annex (4) structure.
• Analytical performance and clinical performance are two separate evidence chains under Annex (7) and cannot substitute for each other.
• Under MDS-G028 Section 4, one TF is recognized when the same clinical and performance evaluation data apply to all products cited in the file.
• IVD bundling caps are a maximum of 5 TFs and 50 items per application.

2. Legal basis

The table below identifies each 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

Exclusion of IVDs from the low-risk simplification is a pathway-level fork. The Saudi 6-item simplified document list excludes five situations: IVDs, sterile devices, devices with a measuring function, reusable surgical instruments, and innovative products. IVDs appear on that list, which means that even a Class A IVD cannot be submitted against the simplified checklist. This runs contrary to expectations: in most markets IVDs are a byword for low risk, yet here they are excluded precisely because reagent performance cannot be judged from a description alone.

This exclusion also echoes the eligibility conditions of the MDNR light pathway: MDNR targets Class A products that are not IVDs, not sterile, have no measuring function, are not reusable surgical instruments, and are not innovative. The two sets of rules share the same exclusion logic, which shows that the SFDA defines what may be submitted with fewer documents in a highly conservative way. For how to choose between the two pathways, see https://www.grzan.cn/regulations/saudi/mdma-versus-mdnr-listing-11 .

Analytical performance and clinical performance are two chains that cannot replace each other. IVD technical documentation must answer two questions at once: whether the reagent can reliably detect the target under laboratory conditions (analytical performance), and whether the result is meaningful for clinical decision-making (clinical performance). The first chain is supported by precision, limit of detection, linearity, interference, and stability studies; the second is supported by comparison against clinical diagnostic conclusions or reference methods.

Under the Annex (7) framework, both chains are consolidated into performance evaluation, but reviewers search them separately. The most frequent deficiency GRZAN encounters is a manufacturer using a single clinical comparison report to cover a gap in analytical performance, or the reverse. The dossier should be organized so that each chain stands as its own chapter with its own conclusion page.

The coupling of Annex (4) with the bundling rules: what counts as one TF. MDS-G028 Section 4 gives IVDs a concrete operational test: where the same clinical and performance evaluation data, covering both analytical and clinical performance, apply to all products cited in the file, the submission is treated as one TF. Official examples include population-specific respiratory virus panels such as Flu A/B together with RSV, panels of drugs of abuse, and tritized quality control materials or calibrators bundled with the kit.

This rule shapes the architecture of the technical documentation in reverse: if Flu A, Flu B, and RSV are placed into the same TF, the performance evaluation chapter of that TF must hold simultaneously for all three products, and cannot be a simple binding of three independent reports. The GRZAN view is that this rule effectively converts saving files into integrating data first, so what is saved is not research workload but the duplicated dossier shell. The full treatment of IVD bundling appears at https://www.grzan.cn/regulations/saudi/mds-g028-bundling-procedure-pack-and-ivd-29 .

One further benefit is easy to miss: IVDs that fall within specified categories, are Class A only, and are not blood specimen collection devices, laboratory mechanical devices, or automated power systems are exempt from the grouping restrictions and the TF count cap, which is highly valuable for pathology consumables and general laboratory consumables manufacturers.

4. Practical recommendations

• Split IVD and device documentation into two separate dossier templates at project initiation, prohibit sharing a common table of contents, and cite Annex (2) and Annex (1) respectively in the essential principles chapters.
• Organize the performance evaluation chapter along the twin tracks of analytical performance and clinical performance, give each track its own conclusion page, and mark the product list covered by each track.
• Where one TF covers multiple products, add an applicable product matrix at the front of the file, row by row, showing which performance data cover each product.
• If bundling is intended, first classify the products into one of the 7 grouping categories in MDS-G028 Section 4, then verify that the testing principle is identical, and only then count whether the TFs and items fall within 5 files and 50 items.
• When citing foreign clinical data, prepare in parallel an identity statement against the version approved by a recognized regulatory authority, for use on the reliance pathway; see https://www.grzan.cn/regulations/saudi/sfda-reliance-pathway-mds-g030-12 .
• Stability, transport, and storage conditions must be explained against local climatic conditions in Saudi Arabia, which relates to the Saudi-specific applicable requirements in the MDS-G030 general eligibility criteria.
• Have the GRZAN regulatory team run one IVD-specific clause comparison before submission, confirming that neither Annex (4) nor Annex (7) has been superseded by a newer version.

5. Verification checklist

• □ Confirmed that Annex (4) applies and the device Annex (3) has not been used by mistake
• □ The EPSP checklist uses the IVD version in Annex (2), not Annex (1)
• □ Confirmed that the low-risk 6-item simplified document list does not apply
• □ Analytical performance and clinical performance are organized as independent chapters, each with its own conclusion page
• □ The applicable product matrix for every TF is completed, and the performance data hold for all cited products
• □ Under bundling, the manufacturer name and address are fully identical, the testing principle is identical, and the grouping category is clearly assigned
• □ The number of TFs does not exceed 5 and the number of items does not exceed 50, including accessories
• □ The current versions of Annex (4) and Annex (7) have been checked (for practical estimate items, verify against 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