Device, Medical Supply, Drug and Cosmetic Boundary in Saudi Arabia

1. Key takeaways

Characterising a boundary product in Saudi Arabia is a precondition, not a question resolved incidentally during submission. Article 1 of M/54 draws the boundary in two sentences: the principal intended action of a Medical Device is not achieved by pharmacological, immunological or metabolic means, although such means may assist it; and the Medical Supply covers medical materials or products used for diagnosis, treatment, replacement, orthopaedic support or disability situations, including medical gases. The updated Product Classification Guide adds that products claiming medicinal efficacy, or with ingredient levels exceeding prescribed limits, may be reclassified as drugs or health products, and cosmetics are limited to external use, without therapeutic substances or claims (a third-party account, practical estimate). Wrong characterisation writes off every subsequent investment, because the submission authority, technical file structure and review pathway all differ.

• Article 1 of M/54 defines Medical Device (principal action not pharmacological, immunological or metabolic), Medical Supply (including medical gases), Assembled Medical Device and Innovative Medical Device.
• Products claiming medicinal efficacy or exceeding ingredient limits may be reclassified as drugs or health products (practical estimate).
• A surgical tray containing a drug requires the marketing authorisation for that drug issued by the SFDA drug sector, plus a component list letter.
• An Assembled Medical Device may contain non-device items; the device characterisation of the set is unchanged.
• MDS-G030 V1.0 application requirement 5 allows SFDA to request supplementary information for combination products, AIeMD and companion diagnostics.

2. Legal basis

The table collects the provisions that decide or affect characterisation at the device, medical supply, drug and cosmetic boundaries.

3. Expert insights

Principal mode of action is the only pivot of the judgement

The M/54 definition of Medical Device uses a negative qualifier: the principal intended action is not achieved by pharmacological, immunological or metabolic means, although such means may assist it. This wording shares its origin with Article 2 of the EU MDR and the IMDRF definition, and leaves a channel for drug-device combinations: where the drug component acts only auxiliarily, the product remains a device, but the review treats it as a combination product. GRZAN’s order of analysis: list all mechanisms of action, rank them by contribution weight; if the drug’s metabolic action is the principal route to the intended use, take the drug channel; if the device’s physical barrier, support or delivery function is the main body, submit as a device with supplementary material on the drug component. The US FDA resolves the same dispute through the Office of Combination Products Request for Designation mechanism; China’s NMPA applies the principle that products acting mainly as devices are registered as devices, with a formal attribute determination procedure. No independent public attribute determination procedure has been seen in Saudi Arabia; as a practical estimate, GRZAN recommends a written e-GHAD classification decision as the characterisation evidence.

Medical Supply is a Saudi specialty and the category Chinese manufacturers most often omit

Article 1 defines the Medical Supply as medical materials or products used for diagnosis, treatment, replacement, orthopaedic support or disability situations, expressly including medical gases. In China such products may sit scattered under device, pharmaceutical packaging or industrial gas regimes, but in Saudi Arabia they are managed uniformly under the devices and supplies law and require an MDMA. Three omissions recur in GRZAN’s practice: medical gases (especially central gas supply systems), rehabilitation orthotic materials, and dressing products with a drug carrier function. Article 1 also defines the Assembled Medical Device — a set assembled to serve different user needs, which may contain non-device items. That matters: a non-device item in a kit does not change the device characterisation of the whole, but MDS-G028 V1.0 requires surgical trays to submit a component list letter itemising the component name, risk class, classification rationale, existing approval number, intended use, and the statutory manufacturer’s name and address.

The three highest-risk product groups: drug-device combinations, functional cosmetics, and health-claim products

The third-party account of the updated Product Classification Guide provides two clear red lines: products claiming medicinal efficacy, or with ingredient levels exceeding the prescribed limits, may be reclassified as drugs or health products; and cosmetics are limited to external use, without therapeutic substances or claims (practical estimate). Three groups carry the highest risk for Chinese exporters. First, drug-loaded dressings and drug-coated devices, such as antimicrobial silver-ion dressings and drug-eluting stents. Second, care products claiming repair, anti-inflammatory or healing-promotion effects: a therapeutic claim on the label or in promotional material may push the product into the drug or health product channel. Third, oral or transdermal health products, which cease to be devices once an ingredient level exceeds the limit. One workable self-check: compare all external claims (website, e-commerce, exhibition material) against the IFU and label in one pass — a single therapeutic claim anywhere triggers re-assessment of the characterisation. SFDA’s advertising requirements follow the IFU, and lay-user advertising must also be in Arabic.

The operating order for drawing the boundary is set out at https://www.grzan.cn/regulations/saudi/sfda-risk-classification-abcd-06 , and the kit component list requirements at https://www.grzan.cn/regulations/saudi/mds-g028-bundling-procedure-pack-and-ivd-29 .

4. Practical recommendations

• Issue a written product characterisation judgement at project initiation: list all mechanisms of action, rank them by contribution weight, and state the device, drug or health product conclusion with reasons.
• Base the characterisation on an e-GHAD classification decision; the application must submit detailed information on efficacy, mechanism of action and intended use (practical estimate).
• Prepare drug-device combinations accordingly: the device part goes through the MDMA, the drug part is supported by composition, content, mechanism of action and safety evidence; where a surgical tray contains a drug, obtain the marketing authorisation issued by the SFDA drug sector.
• Compare all external claims (website, e-commerce, exhibition material, social media) against the IFU and label in one pass, deleting or softening therapeutic claims; lay-user advertising must be in Arabic.
• Check ingredient levels against the limits: where a level approaches or exceeds the prescribed limit, assess early the possibility of reclassification as a drug or health product (practical estimate).
• Prepare the kit component list letter under MDS-G028, filling in the risk class, classification rationale, existing approval number, intended use, and the name and address of the statutory manufacturer for each component.
• For sets containing non-device components, state the rationale under the Assembled Medical Device definition and explain in the technical file that the component does not affect overall safety and performance.
• For combination products on the reliance pathway, reserve time for supplementary information — MDS-G030 expressly allows SFDA to request it based on combination product character.

5. Verification checklist

• □ Product characterisation judgement issued and archived
• □ Written classification decision obtained through e-GHAD (practical estimate)
• □ All mechanisms of action listed and ranked by weight
• □ Composition, content and safety evidence prepared for the drug part
• □ Where the surgical tray contains a drug, the SFDA drug sector authorisation obtained
• □ External claims compared against the IFU and label for consistency
• □ Arabic versions prepared for lay-user advertising
• □ Ingredient levels checked against limits (practical estimate)
• □ Component list letter for kits prepared to the MDS-G028 fields

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