Scope of Federal Decree-Law No. 38/2024: Which Category of Medical Products Covers Medical Devices

1. Key takeaways

Article 2 of Federal Decree-Law No. 38/2024 delimits the scope of application through enumerative drafting: the published text divides medical products into eight major categories, and medical devices (Medical Equipment) are expressly included, applying under the same decree’s system of licensing, vigilance and penalties alongside medicines, biological products and other medical products. For companies, this provision brings two direct consequences. First, medical devices no longer have any space to remain outside the regulation of medical products. Second, the scope of application expressly covers free zones, so medical devices stored in free zones such as DHCC and JAFZA are equally bound. Determining whether a given product falls within Article 2 is the first step of every subsequent filing action.

• Article 2 enumerates eight categories of medical products, with medical devices expressly included.
• Medical devices are subject to the same licensing, vigilance and penalty system as other medical products under the decree.
• The scope of application expressly covers free zones, including DHCC and JAFZA.
• Classifying the product under Article 2 precedes all other filing actions.

2. Legal basis

The table below sets out the provisions that define the scope of application, the prohibition that attaches to it, the separate law governing health-sector software, and the official EDE classification service through which a written classification conclusion can be obtained.

3. Expert insights

Insight 1: Classification as a “medical product” means the whole decree applies, not only Article 2. Our judgement is that once a product is recognised as a medical device within the medical products regime, the mandatory marketing authorization of Article 5, the eight conditions for obtaining it under Article 6, the rights-holder obligations of Article 21, the advertising approval regime of Articles 44–47 and the penalty provisions of Article 160 are all activated together. This explains why some companies that filed under the name of “accessories” or “consumables” were still required to make corrections — once the classification is determined, the entire list of obligations attaches as a whole, and there is no room for performing only a segment of them.

Insight 2: A free zone is not extraterritorial; it is a special scenario of regulation within the territory. Article 2 writes free zones into the scope of application, which directly negates the common understanding that “goods placed in a free zone and not yet declared to customs are not regulated”. Our judgement is that free zones can be used for warehousing and re-export, but once a product is directed at sale within the UAE territory, an EDE marketing authorization must still be obtained and import formalities must be handled through a licensed importer. The import stage carries additional conditions: imports from a fenced free zone require a valid marketing office licence, a GSP certificate issued by the EDE, and a remaining shelf life of at least 12 months.

Insight 3: Software products sit at the intersection of two laws and require parallel assessment. A medical device containing software falls simultaneously within Federal Decree-Law No. 38/2024 and Federal Law No. 2/2019 on the Application of Information and Communication Technologies in the Field of Health. We recommend keeping the two assessments separate: first confirm under Article 2 whether the product is a medical product requiring a marketing authorization, and then verify compliance with patient-data processing under Federal Law No. 2/2019. The two conclusions are independent of each other, and the omission of either will expose risk at the point of actual use.

4. Practical recommendations

• At the project initiation stage, first use the EDE classification service to confirm the product’s attributes; the official timeline is 10 working days, and the classification letter can simultaneously clarify the regulatory category and whether a marketing authorization is needed.
• For combination products (device plus drug, device plus software), determine the dominant attribute according to the principal function and intended use, and explain the combination logic in the classification application documents.
• For warehousing and distribution schemes involving free zones, simultaneously verify applicability under Article 2 and the additional conditions at the import stage, avoiding logistics designed on the assumption of an offshore transhipment.
• For software-based devices with patient-data processing functions, prepare a separate data-compliance verification sheet and manage it apart from the registration dossier.
• Do not make blanket exemption assumptions for products described as “accessories”, “spare parts” or “consumables”; confirm specification by specification and model by model whether a separate marketing authorization is required.
• Within internal processes, treat the classification conclusion as a trigger condition: only where the conclusion is that a marketing authorization is required may the product enter dossier preparation and scheduling.

5. Verification checklist

• □ The classification of the product to be filed under Article 2 has been confirmed, and a written classification conclusion has been obtained.
• □ The basis for determining the dominant attribute of combination products and the accompanying explanatory material have been confirmed as complete.
• □ Warehousing or distribution arrangements in free zones have been confirmed as consistent with the scope of application under Article 2.
• □ The marketing office licence, GSP certificate and 12-month shelf-life requirement for imports from a fenced free zone have been confirmed.
• □ The patient-data processing compliance conclusion for software products (Federal Law No. 2/2019) has been confirmed.
• □ Whether accessories, consumables and spare parts require a separate marketing authorization has been confirmed and the conclusion recorded in writing.
• □ A traceable internal approval record exists linking the classification conclusion to the subsequent filing actions.

Further reading: Article 03 “The Definitional Boundaries of “Medical Equipment” under UAE Law: Reading Articles 1 and 2”; Article 10 “How to Use the One-Year Transition Period: Effective Date, Rectification Obligations and the Start of Penalties”; Article 39 “Free Zones and the Territory: DHCC, JAFZA and the Boundary of Domestic Sales”.

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the United Arab Emirates. Our team manages MOHAP registrations and free-zone (DHCC) pathways, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com