Who Regulates Medical Devices in Iraq

1. Key takeaways

Medical device matters in Iraq are not governed by a single authority; they run along three lines held by three bodies. Business registration and shipment-by-shipment import licensing sit with the Registration Department of the Technical Affairs Directorate of the Iraqi Ministry of Health (DTA). Importation and marketing on the public channel sit with the State Company for Marketing Drugs and Medical Appliances (KIMADIA), founded in 1964, governed by State Companies Law No. 22 of 1997 (as amended) and Rules of Procedure No. 1 of 1999, and associated with the Ministry of Health. Standards and the quality mark sit with the Central Organization for Standardization and Quality Control (COSQC), established by Law No. 54 of 4 June 1979 and listed under the Ministry of Planning, not the Ministry of Health. Writing COSQC up as a standards body under the MOH is a near-universal error in Chinese-language material. GRZAN’s judgment: treating standards conformity and market access as one task to be solved at one window is the number one cause of projects spinning in place.

• Three separate lines: registration (DTA), public procurement and import marketing (KIMADIA), standards and quality marks (COSQC).
• COSQC sits under the Ministry of Planning, not the Ministry of Health, contrary to most secondary sources.
• KIMADIA is a state company and contractual counterparty, not a regulator.
• Enterprise registration and KIMADIA tendering are two gates with different timelines, materials, and remedies.

2. Legal basis

The instruments relied on in this article, with their identifiers, dates, and provisions, are as follows.

Source grade. Public Health Law No. 89: primary, verified (official gazette text reproduced by FAOLEX, marked in force). KIMADIA website statements: primary, verified; the two laws it cites could not be directly retrieved this time, so those are primary with indirect verification. COSQC establishing basis and ministry affiliation: primary, verified at page level. The Registration Department Drug Registration Regulations is a reprint hosted by an overseas industry body and the source site moh.gov.iq was unreachable, so it is secondary reprint / official publication index level, source unreachable; wording must say according to documents published by the Registration Department of the Technical Affairs Directorate of the Iraqi MOH, never Iraqi law provides.

Excerpts:

• KIMADIA website statement: a public company founded in 1964, governed by the general companies law No. 22 of 1997 as amended and the rules of procedure No. 1 of 1999, associated with the ministry of health; wholly state owned, board governed, and under the MOH.
• COSQC website statement: founded in 1979 under Law No. 54 issued on 1979/6/4.
• The list of bodies under the Ministry of Planning on the Ministry’s website includes COSQC; this is the primary basis for saying COSQC belongs to the Ministry of Planning line.

3. Expert insights

Insight 1: the three lines are registration, procurement, and standards, and none is superior to another. The Registration Department decides whether a company can register and obtain shipment-by-shipment import licences; KIMADIA is the state buyer and import-marketing body and decides whom the public channel buys from; COSQC decides whether a product conforms to Iraqi standards and can carry the quality mark. In China the same three functions are held separately by the drug regulator, the purchasers, and the standardisation and inspection bodies; but Chinese purchasers do not run a national import-marketing function, while KIMADIA does both jobs at once, being simultaneously the customer and the import channel.

Insight 2: refutation, COSQC is not in the MOH line. This is the point almost every Chinese-language source gets wrong. COSQC was established by Law No. 54 of 1979, is listed on the Ministry of Planning website among that ministry’s bodies, and its current fee instrument is Instruction No. 4 of 2016. The likely origin of the error is the assumption that standards and health belong in the same ministry. The consequence is practical: submissions on standards conformity routed through the ministry’s subordinate-body path find no accepting window, and a COSQC quality mark does not evidence MOH market access in any review.

Insight 3: KIMADIA is a company, not a regulator. Its own website states that it is self-financing, wholly owned by the state, and holds legal personality with financial and administrative independence. Its power over companies is contractual, not administrative-licensing. Reading its tender notices, guarantee demands, and customs notices as regulatory requirements is another common misalignment; those documents bind through contract and evaluation rules, not administrative law. As a state company executing projects in the investment or recurrent plans it is a contracting entity as defined in Article 1 of the Instructions on the Execution of Public (Government) Contracts No. 1 of 2025, and is bound by that instrument.

Insight 4: two gates, two timelines, two failure modes. To enter the public channel, the first gate is enterprise registration with the Registration Department (legal standing), the second is KIMADIA tendering and award (commercial opportunity). Failing the first leaves the company without a lawful operating identity in Iraq; failing the second leaves identity but no orders. GRZAN manages the two gates on two separate timelines because their documents, durations, and remedies are entirely different; compressing them into one line makes each drag the other down.

4. Practical recommendations

• At project start, GRZAN builds a counterpart table: every action (enterprise registration, import licence, standards conformity, tendering, customs clearance) is annotated with its accepting body and parent ministry, and work begins only after confirmation.
• For standards and quality marks, deal directly with COSQC and follow the Ministry of Planning communication path; never route through the MOH. Practical estimate: the COSQC technical requirements page for imported products requires a login, and document lists follow the accepting window (no official provision found).
• Manage all KIMADIA contact as contractual counterparty management: number and archive tender documents, award letters, and guarantee notices, and separate contractual from administrative obligations.
• In external materials and tender files use the full names, the Registration Department of the Technical Affairs Directorate of the Iraqi MOH (DTA) and the State Company for Marketing Drugs and Medical Appliances (KIMADIA), to avoid ambiguity about the acting entity in reviews.
• Run a rejection debrief: record the body and stated reason for every rejection or supplement request, and use it to correct the counterpart table.

5. Verification checklist

• □ On kimadia.gov.iq/en/about-us/ recheck the founding year 1964 and the numbers and years of the governing laws.
• □ On cosqc.gov.iq/laws/regulation recheck the establishing law number and date (Law No. 54, 1979-06-04).
• □ On the Ministry of Planning website bodies page confirm COSQC is still listed in the Ministry of Planning line.
• □ Search cosqc.gov.iq/laws/instructions to confirm whether fee Instruction No. 4 (2016) has been replaced.
• □ Request from the Registration Department the current enterprise registration document list and window contact details (tec-moh.com returned HTTP 500 during this verification; retry needed).
• □ In the tender documents of any intended bid, check the full name of the contracting party, confirming whether it is KIMADIA or another government entity.
• □ Recheck whether the official documents cited here have been superseded by later instructions or decisions (verification date for this article: 29 October 2026).

Regulatory information verified as of 29 October 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 KMOC (Kurdistan) and federal MOH registration procedures, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com