SFDA Risk Classification of Medical Devices: Classes A, B, C and D

1. Key takeaways

Saudi Arabia assigns medical devices to four risk classes — A, B, C and D — under Annex (5) of MDS-REQ1 V6.0, Risk Classification Rules for Medical Devices, and MDS-G008, Guidance on Medical Devices Classification. This single determination decides four things at once: the depth of the technical file, the fee band of the MDMA, whether the lighter MDNR route is available, and whether the reliance pathway applies (application requirement 1 of MDS-G030 V1.0 is to determine the correct risk class per MDS-G008). From 20 November 2025, new and in-review classification applications fall under the updated Product Classification Guide; decisions must be obtained through e-GHAD, each approval is valid for 1 year from issue, and an objection must be raised within 30 days of receiving the result (a third-party account, treated as a practical estimate, subject to current SFDA announcements). Misclassification costs more than fee correction — it disrupts the MDS-G028 bundling plan, because a family requires the same risk class and, where the components of a system carry different classes, the highest applies.

• The four classes A, B, C and D are determined under Annex (5) of MDS-REQ1 V6.0 and MDS-G008.
• Classification decisions must be obtained through e-GHAD and are valid for 1 year from issue; appeals lie within 30 days (practical estimate, applicable from 20 November 2025).
• MDMA fees by class: Class A 15,000; Class B 19,000; Class C 21,000; Class D 23,000 Saudi Riyal (SAR), plus 15% VAT (practical estimate).
• The classification application fee is SAR 1,000 (practical estimate); innovative products with a patent certificate may be exempt from the classification fee.
• Under MDS-G028, family condition C requires the same risk class, and system condition E requires the highest class where component classes differ.

2. Legal basis

The table lists the instruments that determine classification and its consequences, including the publicly cited fee bands.

3. Expert insights

Why Saudi Arabia puts the classification rules in a REQ annex rather than the legal text

Article 1 of M/54 only defines the Classification System as the system approved by SFDA for evaluating risk classes, delegating the detailed rules to the MDS-REQ layer. This design shares its origin with the EU MDR, which places classification rules in Annex VIII — rules can be upgraded quickly as technology advances without amending the law, but companies must track versions continuously and cannot derive their product’s class from the legal text. In classification work GRZAN screens rule by rule with a documented trail: compare against the rules of Annex (5) and MDS-G008 in order, record why each rule applies or not, and only then state the concluding class. This trail can be submitted directly if the classification decision is queried, and is far more persuasive than a post-hoc write-up.

Three typical misclassifications, and where each one detonates

The first is under-classifying powered therapeutic equipment. Products with energy delivery, closed-loop control or diagnostic decision functions often trigger several rules at once, and the resulting class sits above the R&D department’s intuition. The second is mixing classes inside one application. MDS-G028 V1.0 requires expressly, in condition C for a medical device family, the same risk class, and in condition E for a device system that where component classes differ, the highest applies; bundling a Class B with a Class C device does not pass at the lower class — the whole application is returned for re-planning. The third is overlooking that IVDs run on a separate track — IVDs have their own rule set and the non-IVD rules cannot be applied. China’s NMPA classifies through the Classification Catalogue and determination requests, finer-grained but reliant on determination for out-of-catalogue products; the US FDA assigns a product code and then the pathway. The four-band Saudi structure corresponds on its face to the EU MDR’s I, IIa, IIb and III, but the rule details do not fully match, and copying the CE class across is a common error.

Electronic classification decisions: the rolling maintenance cost of a one-year validity

The updated Product Classification Guide moves classification decisions into e-GHAD for unified management and gives a validity of 1 year from issue with a 30-day appeal window (practical estimate, subject to current SFDA announcements). The scheduling impact is very concrete: classification is no longer a one-off precondition that serves for five years but a rolling task running parallel with the MDMA review cycle. Where the submission cycle exceeds a year, the classification decision can expire mid-review. GRZAN places the classification decision, the MDMA application and the MDMA renewal on one project timeline, scheduling the re-check backwards from the earliest expiry date. Note also that products claiming medicinal efficacy, or with ingredient levels exceeding the prescribed limits, may be reclassified as drugs or health products — not a technical classification question but one of product characterisation and choice of submission route.

The handling order for conflicting classification outcomes is at https://www.grzan.cn/regulations/saudi/mds-g008-classification-rules-07 , and the same-class bundling requirement at https://www.grzan.cn/regulations/saudi/mds-g028-bundling-family-and-system-28 .

4. Practical recommendations

• Screen class by class against the rules of Annex (5) and MDS-G008, and produce a written rule-application trail table retained with the classification application.
• Before submission, download the current MDS-G008 and check the version number and date; its version information has not been officially corroborated (practical estimate).
• Obtain the classification decision through e-GHAD, record the issue date in the project timeline, set a re-check reminder for the 1-year validity (practical estimate).
• Where the classification decision is contested, file the appeal within 30 days of receiving the result (practical estimate), preparing the supporting documents on efficacy, mechanism of action and intended use.
• Lock the classes at the bundling design stage: all devices in a family must share one class, and where the components of a system differ, submit at the highest class.
• Budget by class band: Class A 15,000, Class B 19,000, Class C 21,000 and Class D 23,000 Saudi Riyal (SAR), plus 15% VAT; in practice the GHAD invoice governs (practical estimate).
• Budget the classification determination fee at SAR 1,000 (practical estimate); innovative products with a patent certificate may be exempt from the classification fee, to be checked against current SFDA announcements.
• For products claiming medicinal efficacy or ingredients that may exceed limits, complete the characterisation assessment at project initiation, avoiding forced conversion from the device channel to drug registration after investment.

5. Verification checklist

• □ Rule-by-rule screening against Annex (5) and MDS-G008 done, with the rule-application trail table produced
• □ Current version of MDS-G008 downloaded and version number verified (practical estimate)
• □ Classification decision obtained through e-GHAD, issue date registered
• □ The 1-year validity of the classification decision built into the project timeline (practical estimate)
• □ The 30-day appeal window flagged (practical estimate)
• □ All devices in the application share one risk class, or the highest class applied under the system rules
• □ IVD products classified under the separate IVD rules
• □ Fees budgeted by class band, including 15% VAT
• □ Boundary products completed a device, drug and health product characterisation assessment

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