Mandatory Nature of Marketing Approval: The Red Line of Article 5 and the Two Exemptions

1. Key takeaways

Article 5 of Federal Decree-Law No. 38/2024 is the red line for market access of medical devices in the UAE: without a marketing approval (Marketing Approval, MA), no medical product may be imported, distributed, held, sold, displayed, re-marketed, used or manufactured. This provision covers 8 categories of acts, which means that any single link in the chain from customs clearance to end use can independently constitute a violation. There are only two clearly defined exemptions: products prepared by a compounding pharmacy, and products exempted by a decision of the Cabinet. Our judgement is that the exemptions are narrow exceptions; any unlicensed circulation justified on the grounds of “samples”, “exhibition” or “trial use to gather feedback” must first be tested against Article 5.

• Article 5 prohibits importing, distributing, holding, selling, displaying, re-marketing, using or manufacturing without a marketing approval.
• The prohibition covers 8 categories of acts, each of which can independently constitute a violation.
• The only two exemptions are compounding-pharmacy products and products exempted by Cabinet decision.
• Unlicensed circulation of samples, exhibition units or trial devices must be tested against Article 5.

2. Legal basis

The table below assembles the provisions that define the prohibition, the two exemptions, the exclusive-authorization power, the parallel import and export licensing regime, and the penalty provisions that attach to prohibited products.

3. Expert insights

Insight 1: Article 5 enumerates acts, not entities, which significantly widens its coverage. We read Article 5 as a list of acts: importing, distributing, holding, selling, displaying, re-marketing, using and manufacturing. The reasoning is that these 8 categories of acts correspond to different participants along the supply chain, so that exhibition display at a trade show, holding in a warehouse and hospital trial use may each independently constitute a violation. When designing sample and demonstration processes, a company cannot invoke “no sale has occurred” as a ground for exemption.

Insight 2: Neither of the two exemptions constitutes a routine channel that Chinese companies can invoke. The first exemption targets products prepared by a compounding pharmacy in accordance with its preparation standards, and has nothing to do with industrially manufactured medical devices; the second exemption is decided by the Cabinet case by case and carries no predictability. Our judgement is that building a business plan on a Cabinet exemption carries uncontrollable risk. The compliant path should still return to the eight conditions for obtaining marketing approval under Article 6, or evaluate the applicability of the conditional marketing approval under Articles 8–10 and the emergency use authorization under Articles 11–13.

Insight 3: The marketing approval and the import and export licences are two separate layers; obtaining the former does not discharge the latter. Articles 31–33 provide for import and export licences and their revocation. Our judgement is that companies often read “we already hold the registration certificate” as “we can ship directly”, whereas in reality every consignment still has to go through the import licence procedure. The official timelines of the EDE import licence service are 3 working days for an initial import and 2 working days for clearance on arrival, and the licence is valid for 2 months from the date of issue; these steps must be separately reserved in the logistics schedule.

4. Practical recommendations

• Map each of the 8 prohibited categories of acts under Article 5 onto the company’s internal sales, marketing, warehousing and after-sales processes, identifying the unlicensed risk points.
• Establish a separate approval process for samples, demonstration units and clinical-trial devices, specifying their handling under Article 5 and the documentation requirements.
• Do not write the Cabinet’s discretionary exemption into the business plan; schedule on the basis of the formal marketing approval route.
• Treat the import licence as a scheduling item independent of the registration certificate, arranging shipment timing around 3 working days for an initial import, 2 working days for clearance on arrival and the 2-month validity period.
• State in agreements signed with local partners that no distribution, display or sale may take place before the marketing approval has been obtained.
• Establish inventory segregation and write-off mechanisms for the counterfeit, defective and expired products prohibited by Article 39, avoiding the stacking of penalty exposure.

5. Verification checklist

• □ An item-by-item comparison of the 8 prohibited categories under Article 5 against the company’s internal processes has been completed.
• □ The compliant handling path for samples, demonstration units and clinical-use devices has been confirmed, with approval records retained.
• □ It has been confirmed that the products to be filed do not fall under the compounding-pharmacy exemption, and that no Cabinet exemption is assumed as a planning premise.
• □ It has been confirmed that an import licence is obtained separately for every consignment, and that shipment is completed within the 2-month validity of the licence.
• □ It has been confirmed that the remaining shelf life of goods on arrival is not less than 2/3 of the total shelf life.
• □ It has been confirmed that the cooperation agreements contain clauses prohibiting distribution and display before the marketing approval is obtained.
• □ Inventory segregation and write-off records for defective and expired products have been established.

Further reading: Article 07 “The Eight Statutory Conditions for Obtaining Marketing Approval: Article 6 (a)–(h) Broken Down Item by Item”; Article 10 “How to Use the One-Year Transition Period: Effective Date, Rectification Obligations and the Start of Penalties”; Article 38 “The Two-Stage Import Licence: Pre-Licence, Clearance on Arrival and the 2-Month Validity Period”.

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