Clinical Evaluation and PMCF in Saudi Arabia: MDS-REQ 1 Annex (6) Requirements

1. Key takeaways

Clinical evaluation in Saudi Arabia is governed by Annex (6) of MDS-REQ 1, titled Clinical Evaluation and Post-Market Clinical Follow-Up. Folding PMCF into the same annex shows that the SFDA treats clinical evidence as one continuous chain running from pre-market into the post-market phase, not as two separate reports. Existing foreign clinical data can be reused, provided the device to which the data correspond is identical to the device under application in design, manufacturing process, and intended use. This identity requirement shares one logic with item 2 of the 4 general eligibility criteria of the MDS-G030 reliance pathway, and once it is satisfied the review timeline can be compressed to 35 to 60 working days. Clinical trials conducted inside Saudi Arabia are additionally governed by MDS-REQ 2 (V4.1 / 2022-12-26). Manufacturers of high-risk devices should also consider preparing a Summary of Safety and Clinical Performance under Annex (9).

• Annex (6) merges clinical evaluation and PMCF into one evidence chain.
• The clinical evaluation report must reserve input slots for PMCF data, update frequencies, and re-evaluation triggers.
• Reuse of foreign clinical data turns on identity in intended use, design, and manufacturing process, not on the country of origin.
• Devices cleared by FDA 510(k) substantial equivalence are excluded from the reliance pathway, which interrupts the reuse channel.
• Clinical trials inside Saudi Arabia follow MDS-REQ 2 (V4.1 / 2022-12-26).
• Implantable devices require patient information and an implant card under Annex (8); high-risk devices should consider an Annex (9) summary.

2. Legal basis

The table below collects the instruments governing clinical evidence, their document numbers and dates, the relevant clauses, and the key points of the original text. Regulatory information verified as of October 29, 2026.

3. Expert insights

Merging clinical evaluation and PMCF in one annex changes the time horizon of the file. Placing clinical evaluation and post-market clinical follow-up in the same annex is not a layout choice. It defines clinical evidence as a continuous process: the pre-market evaluation produces an initial conclusion, and PMCF keeps feeding in evidence that corrects the conclusion in return.

For Chinese manufacturers the effect is organizational. The clinical evaluation report cannot be written as a document that is finished upon submission; it must reserve structural slots for PMCF inputs, naming the data sources, the update frequency, and the conditions that trigger re-evaluation. When GRZAN prepares a CER, the PMCF plan is normally given its own chapter with the trigger events for the next update stated explicitly.

Whether foreign clinical data can be reused depends on identity, not on the country of origin. MDS-REQ 1 does not restrict clinical data to studies performed in Saudi Arabia. The real gate is identity: the device to which the data correspond must remain consistent with the device under application in intended use, design, specifications, manufacturing information, and labeling. This wording runs fully parallel to item 2 of the MDS-G030 general eligibility criteria.

The workable route for reusing EU or US clinical data is therefore to complete the identity confirmation in the Rationale of the Reliance Form first, and then hang the same clinical evidence chain onto the Annex (6) structure. Conversely, if any FDA 510(k) device obtained clearance through substantial equivalence, it is explicitly excluded from the reliance pathway and the reuse channel for its clinical data is interrupted at the same time; see https://www.grzan.cn/regulations/saudi/why-fda-510k-excluded-from-reliance-14 .

Comparison with EU MDR and US FDA. The EU MDR requires the CER to argue in layers across the three sources of clinical data, the device itself, equivalent devices, and the literature, and imposes strict equivalence conditions; the Saudi Annex (6) is close to this structure and likewise brings PMCF inside. The US FDA does not use the CER as a universal carrier but requires clinical data separately for 510(k), De Novo, and PMA. China’s NMPA requires clinical evaluation or clinical trials for products outside its catalogue exempt from clinical evaluation.

The practical consequence for Chinese manufacturers is that a CER already written to EU MDR migrates to Saudi Arabia with the marginal cost concentrated on the Saudi-specific applicable requirements rather than on redoing the clinical argument. Companies holding only FDA 510(k) material must rebuild the argument, because the substantial equivalence route is explicitly excluded from the reliance pathway by MDS-G030 and the reuse channel for clinical data is interrupted with it. The relationship among the three major new rules appears at https://www.grzan.cn/regulations/saudi/saudi-2026-regulatory-update-review-49 ; there are 6 recognized regulatory authorities in total, and the eligibility details appear at https://www.grzan.cn/regulations/saudi/reliance-pathway-eligibility-and-rra-13 .

4. Practical recommendations

• Build the CER skeleton to Annex (6) with a separate PMCF plan chapter stating the update trigger conditions.
• When reusing foreign data, complete an identity comparison table covering intended use, design, specifications, manufacturing information, and labeling between the data device and the device under application.
• For clinical trials conducted in Saudi Arabia, prepare the ethics and approval materials in parallel against MDS-REQ 2 (V4.1 / 2022-12-26).
• For implantable devices, prepare the patient information documents and the implant card under Annex (8) at the same time.
• For high-risk devices, consider preparing the Annex (9) Summary of Safety and Clinical Performance to help reviewers locate key findings quickly.
• On the reliance pathway, cite the clinical evidence chain in the Rationale of the Reliance Form and leave room for SFDA requests for supplementary information.
• Serious adverse events or device deficiencies in clinical trials must satisfy the reporting requirements of MDS-REQ 2 and be captured in the NCMDR system.
• Have the GRZAN regulatory team check the current version of Annex (6) and confirm whether the depth thresholds for clinical evaluation have shifted (a practical estimate item).
• When filing several devices in one batch, complete the bundling classification under MDS-G028 first and only then judge whether the whole group qualifies for the reliance pathway; the order of the two decisions must not be reversed.

5. Verification checklist

• □ The CER has been built to Annex (6) with the PMCF plan as an independent chapter
• □ The identity comparison table for foreign clinical data is complete, covering intended use, design, specifications, manufacturing information, and labeling
• □ Whether the device falls within the reliance pathway exclusions has been confirmed (self-registration, substantial equivalence, custom devices, post-market safety issues, SaMD and AIeMD)
• □ Clinical trials inside Saudi Arabia have been tested for approval against MDS-REQ 2
• □ Patient information and implant cards for implantable devices have been prepared under Annex (8)
• □ A written judgment with reasons has been made on whether to prepare the Annex (9) summary
• □ The reporting route for serious adverse events in clinical trials has been written into internal procedures
• □ The current versions of Annex (6) and MDS-REQ 2 have been checked

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