MDS-G008: Applying the SFDA Medical Device Classification Rules

1. Key takeaways

MDS-G008, Guidance on Medical Devices Classification, and Annex (5) of MDS-REQ1 V6.0, Risk Classification Rules for Medical Devices, together form the operational layer of classification in Saudi Arabia: Annex (5) states the rules and MDS-G008 explains how to apply them. Where a product triggers several rules at once, the rules apply in the order they themselves specify; where the rules specify no order, or several rules point to different classes, the highest class applies. It must be noted that the exact number of device classification rules (often cited in the industry as 22) and the current version number of MDS-G008 were not corroborated against official SFDA source text in this review, and must be handled as a practical estimate, deferring to the current version on the SFDA website. Once classification is complete, the classification decision must be obtained through the e-GHAD platform, and that decision is valid for 1 year from the date of issue (practical estimate, applicable to new and in-review applications from 20 November 2025).

• Annex (5) of MDS-REQ1 V6.0 states the rules; MDS-G008 explains their application.
• Where multiple rules point to different classes, the highest class applies, consistent with the approach inherited from the IMDRF framework.
• IVDs are classified by test target and use risk, not by invasiveness or duration of use.
• The device rule count (often cited as 22) and the MDS-G008 version are pending verification (practical estimate).
• Classification decisions are obtained through e-GHAD, valid for 1 year from issue, with a 30-day appeal window (practical estimate).

2. Legal basis

The table below sets out the classification instruments and the documents that invoke them, with the points that matter when running a classification exercise.

3. Expert insights

Why conflicts are always resolved by taking the higher class, and the double-edged effect on Chinese manufacturers

The underlying logic of risk classification rules is the accumulation of the likelihood and severity of harm, not the number of product functions. When a product simultaneously falls under an invasive-device rule, a powered-device rule and a duration rule, taking the highest is the common approach inherited from the IMDRF system, and Saudi Arabia is aligned with EU MDR Annex VIII on this point. The double-edged effect on Chinese manufacturers is this: on one side, the highest-class rule means more functions push the class upward, and multi-function integrated devices are easily driven to Class C or D, raising documentation depth and fees together; on the other side, it provides predictability — once the rule screening is done solidly, the classification result is reproducible and does not depend on communication with the reviewer. GRZAN’s recommendation is to treat taking the highest as a design input: evaluate at the product definition stage the marginal effect of every additional functional module on the class, so that no added feature lifts an entire product line by one band only to be discovered before market entry.

IVDs are a separate track and the non-IVD rules cannot be applied to them

IVD classification does not proceed by invasiveness or duration but by the test target and the risk of the intended use: blood screening, blood grouping, infectious disease markers and human genetic testing carry markedly higher risk weights than routine biochemistry. This is confirmed by the IVD bundling rules of MDS-G028 V1.0, which require IVD bundles to share the same assay principle and to fall within one of the 7 groupings: blood grouping and histocompatibility, cancer and non-malignant tumour markers, human genetic testing, infectious disease markers and immune status, non-infectious physiopathological markers and conditions, and assayed quality control products. The common error GRZAN observes is manufacturers classifying by the physical format of the reagent platform — lateral-flow cassettes or microplates — while ignoring the assay principle and the use grouping, so that the bundling plan does not hold. By comparison, the US FDA manages IVDs by product code and 510(k) exemption status; the EU IVDR applies the seven rules of Annex VIII to assign classes A to D. The Saudi four-band naming matches the IVDR, but the grouping approach is its own system.

The one-year validity of classification decisions: from a one-off act to a recurring obligation

The updated Product Classification Guide moves classification decisions into e-GHAD and gives a validity of 1 year together with a 30-day appeal window (practical estimate, subject to current SFDA announcements). The impact on the reliance pathway is especially direct: MDS-G030 V1.0 lists determining the risk class per MDS-G008 as application requirement 1, while the standard review timeline of the reliance pathway is 35 to 60 working days — if the classification decision expires mid-review, the entire chain must restart. GRZAN’s handling is to run classification and submission as a pipeline: start the MDMA submission immediately after the classification decision issues, and set the expiry reminder so that a buffer remains before the expected MDMA approval date. Note also that the classification application must submit detailed information on product efficacy, mechanism of action and intended use; these materials should remain consistent with the corresponding sections of the technical file, so that two divergent formulations do not trigger a correction request.

The full breakdown of rule application is available at https://www.grzan.cn/regulations/saudi/sfda-risk-classification-abcd-06 , and the bundling impact of IVD groupings at https://www.grzan.cn/regulations/saudi/mds-g028-bundling-procedure-pack-and-ivd-29 .

4. Practical recommendations

• Before assigning a class, download the current versions of MDS-G008 and MDS-REQ1 and verify the version numbers, version dates and rule count (practical estimate).
• Screen rule by rule in order, writing out the reason each rule applies or does not apply; where several rules point to different classes, take the highest and state the basis for taking the higher in the trail document.
• Run IVDs separately under the IVD rules, classifying by assay principle and use grouping; do not carry over the invasiveness or duration logic of non-IVD rules.
• Keep the efficacy, mechanism of action and intended use descriptions in the classification application word-for-word consistent with the corresponding sections of the technical file.
• Start the MDMA submission immediately after obtaining the classification decision, and set an expiry reminder against the 1-year validity (practical estimate).
• Where the classification decision is contested, file the appeal within 30 days with supporting documents (practical estimate).
• For reliance pathway projects, check the classification class against the SFDA Risk Class field in the Reliance Form so the two agree and no correction is demanded.
• For multi-function products, assess at the definition stage the marginal effect of each functional module on the class and keep a written assessment record.

5. Verification checklist

• □ Current versions of MDS-G008 and MDS-REQ1 Annex (5) downloaded and verified (practical estimate)
• □ Rule-screening trail table completed, with reasons for each rule applying or not applying
• □ Multi-rule conflicts resolved under the highest-class principle with the basis stated
• □ IVDs classified by assay principle and use grouping
• □ Classification application material consistent with the technical file descriptions
• □ Classification decision issue date registered and the 1-year validity reminder set (practical estimate)
• □ The 30-day appeal window flagged (practical estimate)
• □ The SFDA Risk Class field of the Reliance Form consistent with the classification decision

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