Implementing Regulation of the Medical Devices Law, SFDA Board Decree No. (3-29-1443)

1. Key takeaways

The Implementing Regulation of the Medical Devices Law was adopted by the SFDA Board through Decree No. (3-29-1443) on Hijri 1443/2/19, corresponding to September 2021 (cited in several SFDA official documents as 26 September 2021), and forms the middle layer connecting the principles of M/54 with the operational detail of the MDS-REQ series. Its value lies in two places: it refines who may do what into licensing and registration procedures, and it supplies the article-level authorisation on which downstream documents such as MDS-G028 and MDS-REQ 11 rest. Articles 3.1, 10/7 and 10/8 are the legislative basis of MDS-G028 V1.0 on Bundling; Articles 10/29, 10/30, 14/1, 16/1, 16/2, 20/2, 20/5, 28/1, 28/2, 30/1, 30/2 and 31/1 are the legislative basis of MDS-REQ 11 V2.0 on post-market obligations. In an appeal or deficiency response, citing the Implementing Regulation carries more weight than citing guidance. GRZAN positions this article as a clause index: it neither repeats the M/54 definitions nor expands the MDS-REQ list, but concentrates the Implementing Regulation articles expressly invoked downstream, so companies can locate the superior basis quickly when drafting responses.

• SFDA Board Decree No. (3-29-1443), adopted on Hijri 1443/2/19, corresponding to September 2021 (also cited as 26 September 2021).
• Articles 3.1, 10/7 and 10/8 anchor the Bundling rules of MDS-G028 V1.0.
• Articles 10/29, 10/30, 14/1, 16/1, 16/2, 20/2, 20/5, 28/1, 28/2, 30/1, 30/2 and 31/1 anchor the post-market obligations of MDS-REQ 11 V2.0.
• Instructions for use and advertising for lay users must be provided in Arabic; the MDMA must state its issue and expiry dates and confers a Marketing Authorization Number and a Medical Device National Listing Number.

2. Legal basis

The table collects the Implementing Regulation provisions that downstream SFDA documents expressly cite, in the order manufacturers encounter them.

3. Expert insights

Why the Implementing Regulation offers the best citation value

The mistake Chinese manufacturers make most often is citing at the two extremes: principles from M/54 and operations from MDS-G. What stitches the two together is the Implementing Regulation. The reason MDS-G028 V1.0 can cap a single MDMA application at 5 technical files (TF) and no more than 50 devices is not the guidance itself but the chain it invokes: M/54 Articles (1), (3) and (8) together with Implementing Regulation Articles 3.1, 10/7 and 10/8. GRZAN’s experience in rejection disputes is that an argument written as a three-level chain — the guidance requires A, its basis is Implementing Regulation Article 10/7, above that sits M/54 Article 3 — is accepted far more readily than a bare citation. Conversely, guidance can be superseded (as MDS-REQ1 Annex (15) was replaced by MDS-G028), whereas the article numbers of the Implementing Regulation are comparatively stable and remain a long-term anchor.

Language requirements and certificate contents: the two most easily overlooked hard constraints

The Implementing Regulation together with MDS-REQ 1 sets the layered language requirements: instructions for use and advertising for lay users must be provided in Arabic, while materials for professional users may be in English or Arabic. The economic meaning is direct — an Arabic leaflet is a mandatory deliverable for products such as home blood glucose meters and home nebulisers, whereas equipment used in hospitals only by professionals may carry an English IFU. The other provision is that the MDMA must state its issue and expiry dates, and simultaneously confers a Marketing Authorization Number and a Medical Device National Listing Number. How many years a certificate is valid therefore has no fixed answer and must be read off the certificate itself; public sources give both a 3-year and a 5-year figure, both a practical estimate. GRZAN recommends managing the MDMA expiry date as a project milestone rather than scheduling renewals on the domestic habit of a five-yearly re-registration.

Comparison with the EU MDR, the US FDA and China’s NMPA

The EU MDR is a text of hundreds of articles plus several annexes, implemented mainly through MDCG guidance; the US FDA’s 21 CFR sits at federal regulation level, supplemented by extensive guidance; China operates a three-layer structure of the Regulation on the Supervision and Administration of Medical Devices, supporting rules and technical guiding principles. The Saudi structure of M/54 plus Implementing Regulation plus MDS-REQ/G is formally closest to the Chinese arrangement, with one substantive difference: the MDS-REQ series consists of mandatory Requirements, not recommended guiding principles. Treating MDS-REQ as optional guidance is the most typical compliance risk in Saudi projects. A second difference lies in updating: Chinese guiding principles are revised slowly and can be re-checked annually, while Saudi MDS-REQ and MDS-G documents are issued by version date — within the last two years alone, new versions took effect as MDS-G011 V2.0 (7 July 2025), MDS-G028 V1.0 (3 May 2026) and MDS-G030 V1.0 (9 September 2026), so re-checking needs to rise to quarterly. The 11 annexes of MDS-REQ 1 V6.0 cover EPSP, technical documentation, clinical evaluation, implant cards, e-IFU and the innovative device summary, leaving no room for optional compliance.

The bundling rules adopted under the Implementing Regulation are examined at https://www.grzan.cn/regulations/saudi/mds-g028-bundling-family-and-system-28 , and the clause-level tracing of post-market obligations at https://www.grzan.cn/regulations/saudi/post-market-surveillance-ncmdr-and-saudi-vigilance-41 .

4. Practical recommendations

• Build a clause-tracing table that maps every submission action back to the specific article of the Implementing Regulation (for example, Bundling to Articles 3.1, 10/7 and 10/8), and write deficiency responses along the three-level chain.
• Cite the Implementing Regulation with the unified formulation Implementing Regulation of Medical Devices Law, SFDA Board Decree No. (3-29-1443), Article (X), noting the Hijri date 1443/2/19.
• Fix the language plan by user type: Arabic instructions and advertising for lay-user products, English for professional-user products, with the layering judgement on record.
• Plan renewal backwards from the expiry date printed on the MDMA certificate; public sources indicate submission at least 90 days before expiry (practical estimate), subject in practice to the GHAD prompts and current SFDA announcements.
• Establish written procedures item by item for the eight post-market obligations (adverse event and complaint reporting, reporting of non-complying devices, safety alerts and FSCA, NCMDR liaison officer, reprocessing, resale, lending and donation of second-hand devices, after-sales and maintenance, and destruction of discarded devices), and name a responsible SFDA contact person.
• Do not treat MDS-REQ as optional guidance: build a conformity matrix line by line as mandatory requirements, stating reasons and alternative evidence for any gap.
• Where the current validity of an article is in doubt, defer to the SFDA website version and gazette announcements, keeping a record of the download date and version number.

5. Verification checklist

• □ Obtained the current text of the Implementing Regulation and checked Decree No. (3-29-1443) and Hijri 1443/2/19
• □ Clause-tracing table covers Bundling, the eight post-market obligations and other key actions
• □ Language-layering plan implemented, with Arabic material ready for lay users
• □ Issue and expiry dates of the MDMA certificate entered in the project milestone table
• □ Renewal reminder set against the certificate date (the 90-day figure is a practical estimate)
• □ Written procedures established and owners named for all eight post-market obligations
• □ MDS-REQ conformity matrix completed, with no item marked as optional
• □ Download date and version number recorded for every document cited

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