Iraq Premarket Pathway: Company Registration Rather Than Product Registration

1. Key takeaways

As of this verification (October 29, 2026), no product-level medical device registration certificate system was identified in any officially reachable channel or officially hosted library for Iraq. According to the Drug Registration Regulations published by the Registration Department of the Technical Affairs Directorate of the Iraqi Ministry of Health, Section D states that medical appliances, disposables and laboratory diagnostic kits themselves are not required to be registered. Because the Ministry of Health website, the Ministry of Justice website and the official legal database were unreachable this round, this finding must not be presented as a claim that Iraq has no product registration. Operationally, companies face two layers: first, the company registration accepted by the Registration Department, whose object is the company rather than the model; second, an import licence for every consignment. For radiation sources the issuing authority is explicitly the Ministry of Trade; for other categories no official provision was obtained. The document carries the header Republic of Iraq / Ministry of Health / Technical Affairs Directorate / Registration Department, yet contains no document number and no publication date, and was obtained only through secondary reproduction. That products need not be registered model by model does not mean that no procedures apply.

• The registration object is the company; the only device-related official amount is the company registration fee of USD 1,000.
• Import permission operates per consignment; for radiation sources the licence is explicitly issued by the Ministry of Trade.
• The Drug Registration Regulations carries no number or date and is hosted on a secondary server: graded secondary, not citable as a legal provision.

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 (the PDF is hosted by Pharmexcil of India 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 Public Health Law is graded primary and verified. The Country Profile 2020 is graded primary, indirectly verified (content obtained through indexed snippets).

Excerpts of the original provisions:

• Introductory sentence of Section D (English original): «Medical Appliances, Disposables products and Laboratory diagnostic kit, themselves are not require to be register».
• Section A item 2 lists the company types that must be registered, including «Medical appliances and disposables producing companies» and «Laboratory diagnostic kit manufacturers» — the registration object is the producer, that is, the company.
• Section A item 3: registration is limited to «any pharmaceutical products, vaccines and sera with a therapeutic effect» — devices are not included.
• Section B item 1: «The responsible authority for registration is MOH/ technical affairs directorate/ registration department».
• Article 42 of the Public Health Law: import, production or sale is prohibited unless a licence has first been obtained from the Ministry in accordance with the instructions it issues for that purpose.
• Scope limitation: the Article 42 licence covers the chemicals and preparations of Article 41, not devices; it is cited only to illustrate the licence-plus-ministerial-instruction mechanism and is not the statutory basis for the device import licence. The clause-by-clause analysis appears in article 04 of this series.

3. Expert insights

Insight 1 | The subject of «not required to be registered» is the product, not the procedure. The most common error is to read «devices need no registration» as «devices need no procedures». Section A item 2 places device manufacturers among the company types that must be registered, and Section D sets out a six-item document list. Registration produces the standing of a company approved to supply Iraq, while every model and every consignment still passes through the import stage.

Insight 2 | Cross-border comparison: the certificates are of an entirely different nature. China’s device supervision regulations (State Council Decree No. 739) issue a product registration certificate specifying model and standards, and the EU MDR (EU) 2017/745 issues CE certificates covering a device family; both take the product as the object of the right. The Iraqi document takes the company as its object: the substance of the file is proof that the establishment exists and is supervised.

Insight 3 | Debunking: the most widely circulated timeline and fee figures cannot be sourced. Market materials, including earlier statements on the GRZAN website, claim 8 to 24 months and official fees of IQD 500,000 to 15,000,000. Neither range was found in any provision across all legally reachable official channels this round (no final assertion is made that no such fee exists, since the Ministry of Health website was unreachable): the only device-related amount in the document is USD 1,000. The likely origin is a splicing of drug review cycles with device timelines. These figures are a practical estimate and are not adopted here.

Insight 4 | The evidentiary grade of this key document must be disclosed. The Drug Registration Regulations has no number or date, is hosted by an Indian industry association, and its style points to roughly 2009. It supports the statement that the Registration Department once published in these terms; it cannot support the statement that Iraqi law provides so.

Insight 5 | Ministry-of-Health issuance is explicit only for radiation sources. The KIMADIA circular of February 2026 states that importers of radiation sources must first obtain authorization from the national nuclear, radiological, chemical and biological control commission, then apply for an import licence from the Ministry of Trade; for other categories no issuing authority was found. The April 2026 circular approved the Arar and Zurbatiyah crossings for medicines and medical supplies, the first confirmation of that device term in a primary document, though other crossings are not excluded.

4. Practical recommendations

• When GRZAN takes over an Iraq project it first performs a level determination: company registration, per-consignment import, or tender eligibility. The three tracks involve different authorities, and mixing them is the main cause of project failure.
• Recognize only officially sourced amounts in the budget: USD 1,000 has an official source; all other alleged expedite, review or data-entry fees are treated as practical estimates.
• Do not apply product-registration timelines to the schedule. Practical estimate: the real milestones are embassy legalization and in-person follow-up, and the first import licence usually takes several months or more (no official provision found).
• Maintain an upstream document calendar: align the validity of the manufacturer’s certificate, the ISO certificate and the legalization in one pass, so the registration is not rejected because a document expires.
• Wherever the Iraqi side demands more than the six items, GRZAN requires the number of the ministerial instruction concerned and manages the demand as an administrative notice.

5. Verification checklist

• □ Open the PDF hosted by Pharmexcil and check the spelling of the Section D introductory sentence and the lists in Section A items 2 and 3.
• □ Once moh.gov.iq is restored, request the current registration requirements list from the Registration Department and confirm whether it is still six items, with a number and date.
• □ Re-check the Arabic original of Article 42 in FAOLEX or ECOLEX and confirm the licence-plus-instruction mechanism.
• □ Check the issuing authority on a sample import licence: whether radiation sources are indeed issued by the Ministry of Trade and who issues the rest.
• □ Search recent Ministry of Health and KIMADIA announcements for any new product-level registration rule for devices.
• □ 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