The Six Documents for Medical Device Company Registration in Iraq

1. Key takeaways

The Iraqi Registration Department requires six items of registration documentation from manufacturers of devices, disposables and in vitro diagnostics (IVD), not the dozen or more items common on service-provider lists. According to Section D of the Drug Registration Regulations published by the Registration Department of the Technical Affairs Directorate of the Iraqi Ministry of Health, the six items are: the company registration form (appendix 4, one copy, signed and stamped by the person responsible for the establishment); a quality assurance system certificate (ISO 9001, 9002 or equivalent); the officially legalized manufacturer registration certificate of the country of origin; the company product data sheet or catalogue; the Israel boycott certification letter; and the company registration fee of USD 1,000. The list contains no Certificate of Free Sale (CFS), no ISO 13485, no pharmaceutical product certificate (CPP) and no letter of authorization — the result of comparing against the Section D list itself; because the Ministry of Health website and the official legal database were unreachable this round, it is not sufficient to assert that Iraq does not require these documents nationally. GRZAN treats the six items as the baseline closest to the official position.

• Item 1: company registration form, one copy, signed and stamped by the person responsible for the establishment, form per appendix 4.
• Item 2: quality assurance certificate such as ISO 9001, 9002 or equivalent.
• Item 3: manufacturer registration certificate in the country of origin, officially legalized.
• Item 4: spread data sheet of the company products, that is, the catalogue.
• Item 5: certification letter regarding the boycott with Israel.
• Item 6: company registration fee of USD 1,000.

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; moh.gov.iq was blocked by Cloudflare and the official original was not obtained). The Country Profile 2020 is graded primary, indirectly verified (the source site was blocked and the content was obtained through indexed snippets).

Excerpts of the original provisions (Section D, item by item in the English original):

• Item 1: «Company registration form to be filled in one copy Signed and stamped by the person responsible on the establishment. (appendix 4)»
• Item 2: «Quality assurance certificate such as ISO 9001, 9002 or equivalent.»
• Item 3: «manufacturer registration certificate in the country of origin officially legalized.»
• Item 4: «Spread data sheet of the company products (catalogue)»
• Item 5: «Certification letter regarding the boycott with Israel.»
• Item 6: «Company registration fee $ 1000.»
• Comparison, Section E item 2 (pharmaceuticals only): «CPP issued by the health authority of the country of origin … legalized officially: from Ministry of Health, Ministry of Foreign affairs and Iraqi Embassy» — the three-tier legalization chain attaches to the pharmaceutical CPP, not to the device registration list.

3. Expert insights

Insight 1 | Four of the six items prove that the company really exists and is supervised. Apart from the catalogue, the registration form answers who the company is and who is responsible, the manufacturer registration certificate answers that it lawfully manufactures at home, the quality certificate answers that it has a system, and the boycott letter and fee answer that it has accepted the conditions of access. No item calls for product performance parameters, test reports, biological evaluation or clinical data — entirely different from the product-registration dossier mindset, under which a company delivers a package both redundant and off target.

Insight 2 | Cross-border comparison: what the equivalent exercise involves elsewhere. Class II and III device registration in China centres on product technical requirements, test reports, clinical evaluation and QMS inspection; Annexes II and III of the EU MDR (EU) 2017/745 require technical documentation and, where applicable, clinical evaluation reports and PMCF plans. Both revolve around evidence of product safety and effectiveness, whereas the pivot of the Iraqi Section D list is entity qualification — a structural reason why Middle East access projects stay costly.

Insight 3 | Debunking: three so-called mandatory documents exist only on service-provider lists. The claims that a CFS is mandatory, that a letter of authorization is mandatory, and that the business licence must be legalized through three tiers cannot be found among the six items of Section D. Two likely origins: transplanting the three-tier legalization chain of the pharmaceutical CPP in Section E onto devices, or mixing the KIMADIA tender qualification requirements discussed in article 12 of this series into the registration stage. GRZAN’s judgement: the registration stage does not need this much, but the tender stage often demands it separately, and the two must be managed apart.

Insight 4 | The detail of one copy betrays the age of the process. Accepting a single paper original, hand-signed and stamped, means the process was designed around paper submission and in-person follow-up, with no electronic channel mentioned. This mirrors the self-description in Section 6.7 of the Country Profile 2020 that review criteria are not public and in-person follow-up is needed. Companies must budget for staff in Baghdad rather than assume a trackable online portal.

Insight 5 | Item 4 is the only place where the product scope becomes visible. It looks the least important yet defines the boundary of the categories approved for supply. GRZAN writes the intended categories into the catalogue accurately and in one pass, keeping the naming consistent with the other documents: a mismatch between the catalogue and the declared import names is a common cause of customs hold-ups.

4. Practical recommendations

• GRZAN converts the six items into a table with owners and due dates at the kickoff; item 3, the legalization of the country-of-origin certificate, usually takes the longest and should start first.
• For item 1, request the latest appendix 4 form from the accepting window (the circulating version comes from the undated PDF); do not reuse old online templates.
• For item 4, use a three-column format of English product name, first four digits of the HS code, and model, aligned with every subsequent import declaration.
• Budget item 6 at USD 1,000 with margin for remittance losses; confirm the payment route and receiving account in writing. Practical estimate: no expedited payments outside compliant channels (no official provision found).
• Log any extra documents demanded by tenderers or agents — a CFS, ISO 13485, a notarized letter of authorization — on a separate list of administrative notices and purchaser requirements, with the cost borne as agreed in the contract.

5. Verification checklist

• □ Compare the English original of the six items of Section D one by one, especially one copy and officially legalized.
• □ Confirm with the Registration Department whether the appendix 4 form is the current version and whether a substitute exists.
• □ Verify whether China’s Medical Device Production Licence can serve directly as the manufacturer registration certificate, and whether legalization is required.
• □ Confirm whether USD 1,000 is still current and whether any notice on exchange-rate adjustment or dinar collection exists.
• □ Verify the actual form of the legalization under item 3, three tiers or two, from the most recent successful filing.
• □ Search whether KIMADIA and the Ministry of Health have added document requirements for IVD reagents in the past two years.
• □ Re-verify whether the official documents cited in this article have been replaced by subsequent instructions or resolutions (verification baseline date: 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