On 9 September 2026, SFDA issued MDS-G30 Version 1.0. This 12-page guidance formally reintroduces the reference-country shortcut withdrawn four years ago, but it is not a return to the old approach: it rebuilds the rules.
1. Start with the timeline
Many industry peers’ first reaction is: “Didn’t Saudi Arabia abolish the GHTF shortcut in 2022? Why is there now a reliance pathway? Has it gone full circle back to where it started?”
To answer that question, we first need to look at what happened over these four years.
Before 2021, Saudi Arabia had an MDNR listing route in addition to MDMA (Medical Device Marketing Authorization). More importantly, SFDA recognized approvals from the founding GHTF members: the United States, Europe, Japan, Australia and Canada. The logic was straightforward: if you had obtained FDA or EU approval, Saudi Arabia generally accepted it.
From late 2021 into 2022, this route was completely closed. SFDA removed the GHTF reference route for MDMA. From January 2022, and then for all classes including Class A from 27 September 2022, all devices were required to follow MDMA plus Technical File Assessment (TFA). Whether or not you held CE marking or a 510(k), you had to submit a complete Saudi technical file to SFDA for SFDA’s own review.
That decision was easy to understand at the time: Saudi Arabia wanted independent review capability and did not want to remain a permanent copy of someone else’s assessment.
But there was a cost. Technical file assessment is labor-intensive. Saudi reviewers reread the same clinical evaluation, risk management and biocompatibility evidence for the same product from the beginning. Substantial review resources were consumed by conclusions that had already been verified, and manufacturers had to repeat a documentation exercise almost identical in structure to EU MDR for a market of 30-40 million people. The written review timeline was 35 working days, but actual project timelines were generally longer. The industry consensus is that, for Class C/D devices, 3-6 months from project initiation to certification counts as smooth; with responses to requests for additional information and queuing, 8 months or more is not uncommon.
On 9 September 2026, MDS-G30 V1.0 was issued. For the first time, Saudi Arabia set out Reliance in a standalone, operational guidance document. Importantly, this is not a restoration of GHTF; it is a new set of rules built around the IMDRF definition of reliance.
2. The first correction: 35 working days is not new
A potentially misleading point must be clarified here: the impression that “it was also 35 working days before” is only half right.
SFDA’s official review target has long been 35 working days. MDS-G30 gives a timeline of 35-60 working days for the reliance pathway, which appears to be longer. If you look only at the numbers, the guidance may seem to offer little value.
But the two figures have completely different meanings:
The old 35-working-day figure was the theoretical review clock for a full Technical File Assessment (TFA), assuming complete documentation, no requests for additional information and no queue. It measured how long the reviewer needed to read the file.
The new 35-60-working-day figure is the overall review timeline for the reliance pathway, and the guidance expressly states that it can be reduced to 35 working days when the conditions are met, because a full independent assessment is no longer required.
In other words, the old rule was to read the entire file in 35 days; the new rule is to read the parts that need to be read in 35 days. The former requires you to submit the entire chain of evidence; the latter requires a chain of evidence that demonstrates identity. The nature of the workload has changed, not merely its duration.
What has really changed is what lands on the reviewer’s desk.
3. What exactly does the guidance change? Five levels
1. From implicit practice to written rules
After 2022, SFDA continued in practice to consider reference-country approvals as supporting documents, but no public document explained which countries’ approvals counted, what had to be submitted, how to make the required declarations, or which products were excluded.
MDS-G30 now sets out all of this: the RRA list (Australia’s TGA, Health Canada, the competent authorities of EU/EEA member states, Japan’s PMDA, the UK’s MHRA and the US FDA), three eligibility criteria, five exclusion categories, a three-step application process, and a Reliance Form on the legal manufacturer’s letterhead.
For regulatory affairs professionals, this is a shift from trying to infer reviewer preferences to delivering against a checklist. Predictability is itself a form of efficiency.
2. The UK has been added to the list, with scope for further expansion
The old GHTF framework covered only five parties: the United States, Europe, Japan, Australia and Canada. MDS-G30 adds the UK’s MHRA to the RRA list, and this is significant. Since Brexit, MHRA’s UKCA system has often occupied an ambiguous position in many markets: accepted, but not explicitly acknowledged. Saudi Arabia has now named it expressly.
The guidance also states that the list will be updated periodically and specifically mentions including jurisdictions of IMDRF Management Committee members. The IMDRF MC currently includes China, South Korea, Singapore and Brazil, among others. This sends a clear signal to companies outside the traditional five parties: the door is open, but their turn has not yet come.
3. MDSAP is formally recognized at the QMS level
The guidance states that SFDA accepts MDSAP certificates and audit reports as evidence of QMS conformity, in order to avoid duplicate audits while maintaining confidence in the manufacturer’s quality management system.
For companies already participating in MDSAP, especially those with market presence in the United States, Japan, Australia, Canada and Brazil, this directly eliminates one round of document organization and explanation costs. For companies holding only ISO 13485 certification, this is not an obstacle, but it does mean one less advantage.
4. The exclusion list: the most important part of the guidance
The five Scope Exclusions are what really determine whether you can use this pathway. One of them contains a pitfall that could catch out many companies:
“Equivalence to a Predicate Routes: Products granted market access primarily by demonstrating substantial equivalence to a predicate device.”
On its face, this provision targets predicate-based medical device routes such as 510(k). But if your product is an IVD and your FDA clearance is a 510(k) with CLIA waiver, or if you used the De Novo route, your US authorization may not be regarded by Saudi Arabia as an authorization based on an independent conformity assessment.
The same logic applies to:
- Market access obtained through self-declaration or self-registration (certain low-risk classes in some countries);
- Custom-made devices;
- Products with a record of significant recalls, suspensions, withdrawals or restrictions imposed by an RRA;
- SaMD and AI medical devices: these may be excluded, rather than being automatically excluded in every case. SFDA decides case by case based on intended use, risk, novelty and complexity.
Note the wording of the last item: `may be excluded`. For AI products, this means that using the reliance pathway is an application that must be actively justified, not a default entitlement. The Rationale section of Annex 1 is, in effect, where you set out that justification.
5. Reliance also extends to post-market surveillance
The final third of the guidance addresses post-market activities: adoption of the IMDRF adverse event terminology and coding systems, including FSCA and FSN, and an explicit statement that SFDA will monitor recalls, field safety corrective actions and other safety information issued by RRAs as inputs for signal detection and risk prioritization.
The legal implications of this half-page carry more weight than the earlier sections: a recall in the United States, Europe or Australia can become the starting point for Saudi action. Reliance works in both directions: if you rely on another authority’s approval, you also inherit its regulatory history.
4. Where, then, are the real advantages?
Put simply, the advantage of this guidance is not greater speed, but less work and greater certainty.
First, the savings are in documentation work, not in the review itself. Under the old pathway, no matter how complete your CE documentation was, Saudi Arabia independently assessed the entire technical file. Under the new pathway, your core task is to demonstrate identity: the same design, the same manufacturing process and the same intended use, together with a checklist-based explanation of Saudi-specific local differences, including Arabic labeling and IFU, voltage, frequency and conductor colors under SBC Part 401, and temperature and humidity conditions for storage and transport. This is a shift from rewriting the entire thesis to writing a comparison statement.
Second, what becomes more certain is the achievability of the timeline, not the number itself. The 35-working-day target changes from a theoretical figure to a conditional commitment. The guidance expressly states the prerequisites: a complete application and complete documentation. Conversely, the document also implies an enforcement approach: incomplete applications do not benefit from this clock.
Third, it creates a strategic entry route in parallel with localization. This point is rarely discussed, but it is critical to timing decisions. Saudi Arabia is advancing healthcare localization under Vision 2030. In public procurement, NUPCO has already applied the practice that imported products are ineligible to bid when a local product is available, while local content (LCGPA) has become a scoring factor. Against this background, a faster, less burdensome and predictable market-access pathway directly affects whether foreign companies still have a window to place products on the market and establish their brands and clinical usage habits before localization thresholds fully come down.
Fourth, the threshold has actually become higher; it has simply moved. Previously, the threshold lay in documentation depth. Now it lies in eligibility assessment and proof of identity. The cost of choosing the wrong pathway has changed from a request for additional information to the entire application being ineligible. This is where the guidance truly filters applicants.
5. Actions to take now
1. Assess eligibility first; do not start with the documents. Review each RRA approval you hold, one by one: was it obtained through an independent conformity assessment, or through predicate equivalence, self-declaration, or an assessment by a third party acting on the authority’s behalf? If this step is wrong, every subsequent investment becomes a sunk cost.
2. Conduct an identity audit. Compare the version intended for the Saudi application with the version approved in the reference jurisdiction, item by item: model, specifications, materials, sterilization method, manufacturing sites, software version, labeling and IFU, and the wording of the intended use. Pay particular attention to apparently harmless localization changes: changing packaging, language or power cords may all require a separate explanation.
3. Prepare Arabic and local technical requirements in advance. Labeling, IFU and user-interface language are mandatory. For electrical equipment, voltage, frequency and conductor insulation colors must comply with SBC Part 401. Temperature and humidity conditions for storage and transport must cover Saudi Arabia’s actual climate. These are not post-review deficiency items; they form part of the market-access conditions.
4. Treat the Reliance Form as a legal document. Annex 1 requires it to be printed on the legal manufacturer’s official letterhead, to declare that the information is true and complete, to confirm that the submitted approvals and documents apply to all devices covered by the application, and to acknowledge that SFDA retains full decision-making authority. The Rationale section must cover three matters: a summary of global registration status; supporting evidence for why reliance is appropriate; and confirmation of identity between the devices in the Saudi application and those covered by the reference approval, including intended use, design, specifications, manufacturing information and labeling.
This is not boilerplate; it is a signed declaration. Writing it too generically hands interpretive discretion to the reviewer.
5. Include post-market exposure in your calculations. What happens in other markets will follow you into Saudi Arabia. A history of global recalls, FSCAs or restrictive measures may be a ground for exclusion at the application stage and remains an ongoing risk exposure after certification.
6. Conclusion: Saudi Arabia is not reopening a door; it is building a road
Looking back over these four years, Saudi Arabia’s approach is clear:
The shortcut was closed in 2022 to build independent review capability. The reliance pathway was introduced in 2026 because that capability has now been established, allowing SFDA to selectively stop repeating work.
These two steps are not contradictory. The first addressed the need to assess files independently; the second addressed the fact that not every file needs to be assessed from scratch. The IMDRF definition of reliance is explicit: the relying authority remains independent, responsible and accountable. It relies on another authority’s assessment, not on another authority’s decision. MDS-G30 repeatedly emphasizes throughout that SFDA retains full decision-making authority, which is precisely how this principle is implemented.
For companies, therefore, the right mindset is not that the shortcut is back, but this: reliance can replace some depth of review, but none of the proof of eligibility or identity can be omitted.
For products already established in the United States, Europe or Japan, this is a clear opportunity to accelerate. For products dependent on predicate equivalence or self-declaration, it is a clear exclusion. For companies still watching the Saudi market from the sidelines, perhaps the most practical message from this guidance is that the window remains open, but it is becoming a window for which you need to queue in advance.
This article is based on publicly available documents and is intended as a reference for understanding. For implementation, please refer to subsequent operational guidance and formal responses issued by the Saudi Food and Drug Authority (SFDA).
Official sources
This article is based on MDS-G30 Version 1.0 issued by SFDA on 9 September 2026. It is provided for industry communication and reference only and does not constitute legal or regulatory advice; specific requirements are subject to the latest text published by SFDA.