Arabic Labelling and IFU: Hard Requirements and Common Errors of Bilingual Compliance

1. Key takeaways

Subparagraph (g) of Article 6(1) makes labelling and the package insert a standalone condition for obtaining the marketing authorization: the inner and outer packaging and the paper or electronic insert must provide the full product information and comply with the EDE labelling guidance. This is not a formality; it is a substantive threshold that can directly cause rejection. Our conclusion is that bilingual labelling should be verified with the Arabic text as the object of review and the Chinese or English text as the reference, because when the product circulates within the UAE, the Arabic text is the text on which regulators and users actually rely.

• Article 6(1)(g) makes complete packaging and insert information an independent condition for authorization.
• Labelling failures are a substantive rejection ground, not a formality.
• The Arabic text is the object of review; the Chinese or English text serves only as the comparison.
• The Federal Law No. 8 of 2019 has been repealed and the EDE labelling guidance now governs.
• One master label text should serve registration, customs clearance, and advertising approval alike.
• Electronic inserts are acceptable provided the access path is stated on the label.
• Articles 44 to 47 require advertising approval by EDE, and Article 46 allows the applicant to choose a validity period of 30 days to 1 year.
• Because the same wording is reused at three stages, a single master label text keeps registration, clearance, and advertising aligned.
• Any modification starts from the master text and is synchronized outward to all three stages.

2. Legal basis

The regulatory basis combines subparagraph (g) of Article 6(1) of Federal Decree-Law No. 38 of 2024 with the prohibition provisions and the institutional mandate that govern labelling. The table below reproduces the instruments cited in the source material and their key points.

3. Expert insights

Insight 1: The issuing body of the labelling guidance has changed with the institutional transition. Federal Law No. 8 of 2019 has been repealed by Federal Decree-Law No. 38 of 2024, and the EDE, established under Federal Decree-Law No. 28 of 2023, took over the registration, classification, pricing, and vigilance services previously performed by MOHAP. Our judgment is that any product still using the legacy MOHAP labelling template should be re-verified against the current EDE guidance, especially in the presentation of the manufacturer and local authorised representative information.

Insight 2: Electronic package inserts are explicitly accepted, but the access condition must be stated. Subparagraph (g) of Article 6 lists both paper and electronic inserts, which gives electronic form legitimacy. Our recommendation is that high-risk devices used by professional institutions may adopt electronic inserts, but the access path must be stated on the label; for products aimed at individual users or home settings, a paper Arabic insert should remain the primary form, so that the access path does not become a barrier to use.

Insight 3: The label is the hub of cross-stage consistency. The same set of label wording appears in three places: the marketing authorization submission, import customs clearance, and advertising approval. Articles 44 to 47 of the Decree-Law require advertising to be approved by EDE, and Article 46 allows the applicant to choose a validity period of 30 days to 1 year. Our practice is to maintain a single master label text shared by all three stages; any modification starts from the master text and is synchronized outward, otherwise wording differences at the clearance and advertising stages are directly identified as inconsistencies.

4. Practical recommendations

• Establish the master label text with the Arabic wording as the object of review, using the Chinese or English text only for comparison.
• Re-verify legacy templates against the current EDE labelling guidance, focusing on the manufacturer and local entity information fields.
• Compare the inner and outer packaging artwork item by item against the package insert, keeping models, batch number formats, and warnings consistent.
• Where an electronic insert is used, state the access path on the label and describe the intended users and settings of use.
• Use the master label text for the registration submission, import clearance, and advertising approval alike, and initiate any modification synchronously.
• Have the Arabic translation reviewed by personnel with a medical device background to keep terminology and intended use faithful.

5. Verification checklist

• □ Inner and outer packaging artwork has been provided per the EDE labelling guidance, with complete Arabic information
• □ The paper or electronic insert format has been decided, and electronic inserts state the access path on the label
• □ The product generic name and models in the Arabic text match the application form
• □ Warnings, contraindications, and precautions correspond item by item with the risk management documentation
• □ The presentation of the manufacturer name, address, and local authorised representative information meets current requirements
• □ The master label text has been synchronized across the registration, clearance, and advertising stages

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 prepares MOHAP-compliant dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com