Language Requirements: Arabic and English in Iraqi Applications

1. Key takeaways

The Iraqi language requirements amount to only two sentences of official text: application forms are accepted in Arabic and English («Arabic and English are the accepted languages for the application forms»), and scientific data must be in English («Scientific data should be in English»). Both come from Section B items 5 and 6 of the Drug Registration Regulations published by the Registration Department of the Technical Affairs Directorate of the Iraqi Ministry of Health — a document with no document number, no publication date and only secondary reproduction, graded secondary and not citable as a legal provision. From this it does not follow that Arabic labelling of devices is mandatory: the labelling clause of item 24 of that document sits in the section on pharmaceutical registration requirements, and the device part contains no corresponding provision. As of October 29, 2026, no provision requiring medical device labels and instructions for use to be in Arabic was retrieved from any legally reachable official channel or officially hosted library; because the Ministry of Health website, the Ministry of Justice and the official legal database were unreachable, this conclusion must not be presented as a claim that Iraq does not require Arabic labels. That proposition is a practical estimate.

• Application forms: Arabic and English are both accepted languages, per Section B item 5.
• Scientific data: English, per Section B item 6.
• Labelling: the only labelling clause, Section E item 24, belongs to the pharmaceutical product registration requirements; the device list of Section D demands no label samples.
• The chain of contrast runs: application forms in Arabic or English, scientific data in English, labels only within the pharmaceutical clauses.

2. Legal basis

The table below lists the sources cited in this article together with their document numbers, publication dates and the provisions relied upon.

Source grading: the Drug Registration Regulations is graded secondary and must not be cited as a legal provision (hosted at https://pharmexcil.com/uploadfile/ufiles/380351111_drug_regpdf.pdf; the official original was not obtained). The others are graded primary and verified, and primary, indirectly verified (the source site was blocked and the content was obtained through indexed snippets), respectively.

Excerpts of the original provisions:

• Section B item 5 (English original): «Arabic and English are the accepted languages for the application forms.» — at the level of application forms, Arabic and English are both acceptable.
• Section B item 6 (English original): «Scientific data should be in English.» — scientific data must be in English.
• Section E item 24 (for contrast): a labelling clause under the section on pharmaceutical product registration requirements. Its position shows that the object of the labelling-language constraint is pharmaceuticals; none of the six items of Section D, the device list, requires label samples.
• The resulting chain of contrast: application forms in Arabic or English, then scientific data in English, then labels appearing only in the pharmaceutical clauses.

3. Expert insights

Insight 1 | The submission language of the authorities and the product language are two different matters. The clauses govern the language of submitted documents, that is, whether the window can understand the file: application forms must be readable by officials, hence Arabic alongside English; technical data need no Arabic translation, English suffices. This lowers acceptance barriers without adding translation cost, and it is not the same stage as the localization of labels when the product reaches the user. Superimposing the two layers is the technical path that produced the claim of mandatory Arabic labels.

Insight 2 | Cross-border comparison: where mandatory local-language labels usually sit. China’s Provisions on the Administration of Medical Device Instructions and Labels (former NMPA Decree No. 6) require Chinese on labels and instructions; several Gulf states require Arabic labels to be submitted and reviewed as registration materials; Article 9 paragraph 5 of the EU MDR (EU) 2017/745 requires instructions for use supplied with the device to be in the official languages of the member states. All of these are obligations at the level of product registration and post-market supervision.

Insight 3 | Debunking: the claim that all technical documents, labels and instructions must be translated into Arabic by an Iraqi-approved translation body was not found in any official source this round. What article 01 of this series did was to search the full text of the 106 articles of Public Health Law No. 89 of 1981 word by word in Arabic, without finding the core terms for label — this negative tally is an objective count over a text actually obtained and may be stated firmly. As for the so-called Iraqi-approved translation bodies, no founding basis or directory was retrieved from any legally reachable official channel either. Because the Ministry of Justice and the official legal database were unreachable, this is only a failure to retrieve, not a final conclusion that no such bodies exist.

Insight 4 | Why Arabic labels are nevertheless recommended. Three layers of reasons, none statutory. First, tendering: tender documents often write Arabic instructions into the technical specifications. Second, end users: clinical users work in Arabic. Third, customs clearance and acceptance: the cost of explaining a purely English label when the window raises questions.

Insight 5 | The correct internal drafting is layered management. GRZAN labels three classes of content separately in its deliverables: application forms in Arabic and English as a must, with an official source; scientific data in English, with an official source; and product labels and instructions in Arabic, classified as purchaser requirements and practical convention. This avoids losing marks for an omission and preserves the room for defence if the characterization is ever challenged.

4. Practical recommendations

• Configure the submission in two layers: application forms in a parallel Arabic-English version, product technical data and catalogue in English; have the Arabic translation reviewed by a native speaker to avoid machine translation being rejected at the window.
• Do not translate the entire technical dossier into Arabic in advance at home. Practical estimate: where Arabic is needed, start with the minimal set of labels, brief instructions for use and warnings (no official provision found).
• Tender documents are the hard source for label language: GRZAN compares the language clauses of the technical specifications item by item during bid preparation and treats them as the sole execution basis.
• Manage consistency between the two language versions: product names, models, manufacturer addresses and registration numbers must match exactly in Arabic and English; discrepancies are a classic cause of customs holds and acceptance rejections.
• Fix the boundary of responsibility for language in the contract: translation costs arising from a purchaser adding language requirements after award are borne by the demanding party.

5. Verification checklist

• □ Check the English original and section position of Section B items 5 and 6.
• □ Check the section heading of the labelling clause in Section E and confirm it sits under the pharmaceutical product registration requirements, not the device section.
• □ Re-search the full text of Public Health Law No. 89 of 1981 for the Arabic terms relating to labels and confirm zero hits in the device context.
• □ Search the current KIMADIA tender announcements and the standard tender documents to confirm how the label-language clauses are actually drafted in tendering.
• □ Confirm in writing with the Iraqi window whether the language of submitted documents and the language of product labels are required separately.
• □ Unify the Arabic and English renderings of product names, models and manufacturer information into a controlled vocabulary.
• □ Re-verify whether the official documents cited in this article have been replaced by subsequent instructions or resolutions (verification baseline date of this article: October 29, 2026).

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 Iraqi market. Our team manages federal and Kurdistan registration applications, prepares reference-country dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com