Reliance Pathway Eligibility and the Six Recognised Regulatory Authorities

1. Key takeaways

The eligibility threshold of MDS-G030 (V1.0 / 2026-09-09) consists of two general criteria plus three Saudi-specific requirements. The first general criterion is holding at least 1 valid marketing authorisation or approval issued by an RRA; the six RRAs are Australia’s TGA, Canada’s Health Canada, the competent authorities of the EU/EEA member states, Japan’s PMDA, the UK’s MHRA and the US FDA, and the SFDA states it will update the list periodically and may add IMDRF Management Committee member jurisdictions. The second is technical identity — complete identity with the RRA-approved device in design, manufacturing process and intended use; these three are a conjunction, not alternatives. The Saudi-specific requirements cover: supply voltage, frequency and conductor insulation colours under Part 401 of the Saudi Building Code (SBC); the content and language of labels, IFU and user interfaces; and storage-transport requirements related to temperature and humidity control. MDS-G030 also lists five application requirements: classify under MDS-G008, bundle multi-device applications under MDS-G028 (at most 5 technical files and 50 items), provide evidence of the RRA approval, submit the Annex (1) rationale, and accept SFDA requests for additional information on AIeMD, companion diagnostics and combination products. Regulatory information verified as of 29 October 2026.

• Eligibility = at least 1 valid RRA approval + technical identity in design, manufacturing process and intended use.
• The six RRAs: TGA, Health Canada, EEA competent authorities, PMDA, MHRA, FDA; the list may be updated with IMDRF member jurisdictions.
• Saudi-specific requirements: SBC Part 401 electrics, label/IFU/interface language, and temperature-humidity storage-transport conditions.
• Five application requirements include MDS-G008 classification and MDS-G028 bundling limits (5 technical files, 50 items).

2. Legal basis

The following instruments set out the eligibility criteria, the Saudi-specific technical requirements and the language obligations that apply on top of the general criteria. Third-party retellings are marked as practical estimates with their verification actions.

3. Expert insights

1. The word identical is harder in the text than it looks

MDS-G030’s wording in the general eligibility criteria is technically identical, landing on three points: design, manufacturing process and intended use. Each points to a different evidence pack: design is judged from engineering drawings, bills of materials and specifications; the manufacturing process from process flows, validation of critical steps and the production site list; intended use from labelled indications, patient populations and the use environment. Many Chinese manufacturers stumble on the third — to fit a Middle East distributor’s needs they extend an indication in the English IFU or delete a contraindication, and in the SFDA’s eyes the device is no longer the one the RRA approved. The Reliance Form’s Rationale field reserves a dedicated identity-confirmation slot covering intended use, design, specifications, manufacturing information and labelling, precisely to put this comparison in writing.

2. Why local technical requirements such as SBC Part 401 are preconditions

The premise of reliance is that someone else has already assessed core safety and performance, but one class of risk cannot be assessed abroad: what happens once the equipment is installed into the local grid. Mismatched supply voltage or frequency directly affects safety and performance; conductor insulation colours bear on personal safety during installation and servicing on site — such requirements are carried by the building code, not the device regulation. By writing them into the eligibility clauses, the SFDA declares that reliance covers the product itself, not its use environment in Saudi Arabia. The same logic applies to Arabic labelling for lay users and to storage-transport requirements targeting local high temperature and humidity: these are the parts no foreign assessment can substitute.

3. The six RRAs are not equal in depth

The assessment depth behind the six authorities varies widely. Conformity assessment under the EEA’s MDR, Health Canada’s MDL review, TGA’s ARTG inclusion and PMDA’s approval each demand different technical file depth and involve third parties to different degrees — which determines how much the SFDA can actually rely on. An operational test: take the technical file list you submitted to that RRA; if it can be tailored into the structure of MDS-REQ1 Annex (3) or Annex (4), the cost advantage of reliance holds; if most of it must be rewritten, the conventional MDMA route may not be slower. On why the US route carries its own snag, see https://www.grzan.cn/regulations/saudi/why-fda-510k-excluded-from-reliance-14 ; the pathway overview and the time account are in https://www.grzan.cn/regulations/saudi/sfda-reliance-pathway-mds-g030-12 .

4. Practical recommendations

• Build an approval matrix: every SKU × every RRA, marking approval status, approval number, approval date and expiry date, as the evidence ledger.
• Produce a technical identity comparison table with three columns — design, manufacturing process, intended use — giving row-by-row differences between the RRA version and the version to be filed; write no difference rather than leaving blanks.
• Subtract SKUs first: remove models whose labels or specifications were modified for local sales from the first reliance round and run them through the conventional channel separately.
• Have a Saudi local engineer verify supply voltage, frequency and insulation colours unit by unit against SBC Part 401, and keep the check records.
• Where approvals exist in several countries, choose the RRA with the most complete technical file as the reference authority and state the reason in the rationale.
• If the product line involves AIeMD, companion diagnostics or combination products, reserve time and expert resources for additional information requests from the start.
• Re-read the RRA list footnotes before every submission to confirm whether IMDRF member jurisdictions have been added. GRZAN archives the version and date of that footnote as evidence of the submission point in time.

5. Verification checklist

• □ The RRA to be relied on is selected, with the approval valid and not withdrawn or restricted
• □ The technical identity comparison table covers design, manufacturing process and intended use
• □ The version to be filed has not modified the RRA-approved device, especially the intended use
• □ SBC Part 401 voltage, frequency and conductor colours have been checked or remediated
• □ Label, IFU and user-interface languages have been layered by user (lay user / professional user)
• □ Storage-transport conditions have been re-assessed for Saudi high temperature and humidity, with transport validation or explanatory documents
• □ Risk classes re-verified against the current MDS-G008; multi-device applications checked against the 5-file / 50-item limits of MDS-G028
• □ The Annex (1) rationale contains all three parts: global regulatory status summary, evidence of the appropriateness of reliance, and identity confirmation
• □ Products covered by the five Scope Exclusions have been removed from the submission list

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 manages SFDA MDMA applications across classes, prepares reference-approval dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzan.com