Overview of the SFDA Regulatory System for Medical Devices in Saudi Arabia

1. Key takeaways

Regulatory authority over medical devices and supplies in Saudi Arabia is concentrated in a single body, the Saudi Food and Drug Authority (SFDA); there is no power-sharing with the Ministry of Health or the Ministry of Commerce. The rule set forms a four-tier pyramid: the Law of Medical Devices and Supplies (Royal Decree No. M/54, Hijri 1442/7/6, corresponding to 18 February 2021); the Implementing Regulation of the Medical Devices Law (SFDA Board Decree No. (3-29-1443), Hijri 1443/2/19, corresponding to September 2021); the mandatory MDS-REQ series; and the MDS-G guidance series. For Chinese manufacturers only three nodes truly need managing: entity-side qualification (MDEL), product-side marketing authorisation (MDMA), and the data maintained continuously in GHAD and Saudi-DI. Every argument chain in a dossier must be cited top-down — law, implementing regulation, REQ, G — because reversing that order leaves a response without a defensible foundation.

• Royal Decree No. M/54 was published on 18 February 2021 in Umm Al-Qura issue No. 4872 of 26 February 2021; Article 1 carries the full set of official definitions.
• The Implementing Regulation was adopted by SFDA Board Decree No. (3-29-1443) on Hijri 1443/2/19, corresponding to September 2021, cited in several official SFDA documents as 26 September 2021.
• MDS-REQ1 V6.0 (19 December 2021) holds the marketing authorisation requirements; MDS-REQ9 V1.0 (31 July 2022) covers establishment licensing conditions (practical estimate).
• The unified GHAD electronic system went live in December 2019 and fully replaced the legacy systems on 27 September 2022 (practical estimate).

2. Legal basis

The table consolidates the instruments cited in this guide, their reference numbers, publication dates and the articles most often traced in a response to SFDA.

3. Expert insights

Why Saudi Arabia places devices and supplies under one law

The full title of M/54 is the Law of Medical Devices and Supplies. Article 1 defines Medical Device and Medical Supply separately, the latter covering medical materials or products used for diagnosis, treatment, replacement, orthopaedic support or disability situations, and expressly including medical gases. Low-value consumables such as gauze and infusion sets therefore share the same marketing authorisation logic as implantable devices; the difference lies in risk class and documentation depth, not in the regulatory system. The commonest misjudgement GRZAN sees is manufacturers treating consumables as non-devices out of Chinese habit and selecting the wrong GHAD activity type. Conversely, the unified design carries a dividend: one MDEL and one set of post-market procedures can cover devices and supplies under the same licence holder, without split applications.

SFDA’s two levers: it regulates both Establishments and Circulation

Article 1 defines an Establishment as a legal person carrying out activities related to medical devices and supplies, and Circulation as the provision of devices or supplies with or without payment, whether by distribution or by use. These definitions are SFDA’s jurisdictional triggers: once a legal person carries out such activities in Saudi Arabia, or a provision takes place, the matter falls within scope. Having no local company therefore does not mean having no obligation — where there is no Establishment the route runs through an Authorised Representative (AR) — and free-of-charge scenarios such as exhibition samples, donations and research use are not automatically outside scope, since any exemption depends on MDS-REQ5 and MDS-G011. Compared with the EU MDR trigger of making available on the market and the US FDA test of commercial distribution, the Saudi definition is broader because it expressly captures use. GRZAN recommends placing MDEL, MDMA and Saudi-DI milestones on one timeline, since MDMA needs entity qualification or an AR first while Saudi-DI data must stay synchronised with the MDMA model list; planned serially, time to market is decided by the qualification stage rather than the technical documentation.

Comparison with China’s NMPA and the EU MDR: how much of one technical file must be rewritten

The overall skeleton of the Saudi technical documentation (TF) closely mirrors EU MDR Annex II/III. MDS-REQ1 Annex (3) for devices and Annex (4) for IVDs can largely reuse an existing CE technical file, but three rewrites are mandatory. First, the Essential Principles of Safety and Performance (EPSP) must be argued item by item against the entry numbers of MDS-REQ1 Annex (1) and Annex (2); MDR GSPR numbering cannot be carried over. Second, instructions for use and advertising aimed at lay users must be provided in Arabic, while materials for professional users may be in English or Arabic. Third, labelling must overlay Saudi-specific requirements such as Part 401 of the Saudi Building Code on supply voltage, frequency and conductor insulation colours. Powered-device manufacturers stumble here most often: a 220V/50Hz product keeping a European-standard nameplate unchanged is frequently asked for supplementary explanation during review.

A full breakdown of the four-tier regulatory pyramid is at https://www.grzan.cn/regulations/saudi/mds-req-vs-mds-g-hierarchy-04 , and the institutional significance of the submission gateway at https://www.grzan.cn/regulations/saudi/ghad-electronic-portal-10 .

4. Practical recommendations

• Run a system mapping before project initiation: match every product on the submission list to the definitions of M/54 Article 1, confirming whether it is a Medical Device or a Medical Supply, so the GHAD activity type is not selected wrongly.
• Build an internal four-tier Saudi regulatory index table in the columns law, implementing regulation, REQ and G, recording the version number and version date at every citation; MDS-REQ1 is currently V6.0 / 19 December 2021.
• For powered products, confirm electrical parameters with R&D early, check voltage, frequency and conductor insulation colours against Part 401 of the Saudi Building Code, and revise nameplate and instructions in step.
• Layer the language of instructions by user type: issue Arabic versions for lay-user content, keep English for professional-user content, and record the layering rationale in the technical file.
• Manufacturers without a Saudi legal entity should complete AR agreement signing, notarisation and legalisation before submitting the MDMA; the AR must be a legal entity located within Saudi Arabia (M/54 Article 1).
• Assign data ownership in GHAD and Saudi-DI to named individuals: model names, GMDN codes and similar fields are submitted and maintained by the manufacturer or the AR, and new UDI-DI data must be on file at market placement.
• The article numbers and licensing conditions of MDS-REQ9 were not obtained in this verification; before the MDEL application, download the current version from the SFDA website and check it (practical estimate).

5. Verification checklist

• □ Confirmed whether each product is a Medical Device or a Medical Supply, and selected the correct GHAD activity type
• □ Obtained current English texts of M/54 and the Implementing Regulation, with traceable article citations
• □ Registered the version and version date of MDS-REQ1 V6.0 / 19 December 2021 in the internal regulatory index
• □ Checked powered products against Part 401 of the Saudi Building Code
• □ Recorded the language-layering conclusion in the technical file, with Arabic lay-user versions ready
• □ Confirmed the AR’s entity eligibility and the written chain of authorisation (legal entity within Saudi Arabia)
• □ Designated the person responsible for Saudi-DI data, with UDI-DI data consistent with GHAD
• □ Downloaded the current MDS-REQ9 and checked licensing conditions before the MDEL application (practical estimate)

Regulatory information verified as of 29 October 2026.

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 medical device marketing authorisations and Saudi Authorized Representative arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com