Who Holds the Registration Certificate: Company Registration and Scientific Bureau Representation in Iraq

1. Key takeaways

Iraq does not issue a medical device registration certificate that names a product; manufacturers can neither obtain one nor need one. What is called holding a licence in Iraq settles on two layers: the manufacturing company completes a company registration with the Registration Department of the Technical Affairs Directorate (DTA) at the Iraqi Ministry of Health, and a registered Scientific Bureau in Iraq acts as the local representative that carries the import and follow-up work. The accurate answer is therefore that there is no certificate to hold. What exists is a registration file and a representative qualification, both attached to the declaring entity.

Under the agent-attachment model, that file and that qualification all sit in the agent’s name. The manufacturer holds exactly one power of attorney, cannot recover the file when cooperation ends, and cannot continue declaring imports in its own name. GRZAN adopts a self-operated entity holding arrangement: a GRZAN entity in the target market serves as the registration and representative entity, while ownership and control of the file return to the manufacturer through contractual arrangements. This article is a business-model explanation; all timelines and fees are stated as a practical estimate.

• No product-level certificate exists at the device layer; the registration target is the manufacturing company.
• The registration file, the representative qualification and the import licence records all sit in the name of the declaring entity.
• Under agent attachment the manufacturer keeps one power of attorney and loses practical control of the file.
• GRZAN’s self-operated entity model keeps contractual ownership and control of the file with the manufacturer.

2. Legal basis

The instruments below frame who may register and who may represent in Iraq. The verification status of each item follows the source review and is stated per row.

Extracts of the operative provisions. The KIMADIA notice of June 2026 is addressed to «all companies and all Scientific Bureaus», which is primary corroboration that the Scientific Bureau system genuinely exists, since the official announcement takes them directly as its addressees. Article 10 of Instruction No. 1 of 2025 requires each bidder to submit the certificate of incorporation, the articles of association, the company’s internal rules and the power of attorney for representation and signature, so the identity and authorisation chain of the bidding entity must be self-evidenced on paper. Section D of the Drug Registration Regulations states, in its own English wording, that Medical Appliances, Disposables products and Laboratory diagnostic kit, themselves are not require to be register — devices, consumables and laboratory diagnostic kits as such need no registration, and the object of registration is the manufacturing company.

3. Expert insights

Who holds the certificate is a pseudo-question; the real question is who holds the file. With no product certificate at the device layer, the assets a company can assert reduce to three: the company registration number with the Registration Department, the Scientific Bureau representative qualification, and the declaration records of successive import licences. Under the agent-attachment model all three are registered in the agent’s name. When GRZAN assesses an Iraq project it asks first whose name the file is titled in, before any discussion of timelines and fees.

A comparison with the European Union and China shows that the difference lies in the level at which the licence is held. Under the EU MDR the manufacturer remains the registration subject and the EU authorised representative carries only liaison and technical-documentation duties; China’s regulatory framework establishes a structure in which the foreign registrant holds the certificate itself while a domestic designated agent handles liaison and reporting. Iraq differs because the holding level is company registration rather than product registration, and the Scientific Bureau therefore holds the sole gateway to the file in practice. A manufacturer that changes service providers in the EU only changes its authorised representative; in Iraq the same change may mean walking through company registration again.

Debunking the claim that an Iraqi medical device registration certificate is valid for five years and is then renewed. The claim fails at two points. First, company registration is not a product registration certificate, so there is no certificate to renew. Second, the official position (Pharmaceutical Country Profile 2020, §6.5, Ministry of Health) is that registration information is recorded, reviewed and updated every five years, and registration is automatically cancelled if updated information is not submitted on time — that is an information review cycle, not a certificate validity period.

The price of agent attachment is exit cost, not entry cost. The entry threshold is only a signed power of attorney; the cost appears at exit. File migration requires the former agent’s cooperation and termination documents, the Scientific Bureau representation must be re-appointed, and ongoing public tenders may be affected by the change of bidding entity. Negotiation of the agency agreement should therefore focus not on the first-year service fee but on exit clauses and file-transfer clauses.

4. Practical recommendations

• GRZAN’s first action on an Iraq project is to ask the client for the titled entity and the registration number of the existing company registration, to confirm whether the file sits on the manufacturer’s side or the agent’s side; where it sits with the agent, add file-transfer and termination-cooperation clauses first.
• Adopt the self-operated entity holding arrangement: a GRZAN entity in the target market acts as the registration and representative entity, with ownership and control of the file returning to the manufacturer by contract. Practical estimate: entity arrangement and file migration take 4–8 weeks (no official provision found).
• Write the signing level, term and revocation mechanism of the power of attorney into the contract; once a power of attorney is unlimited in time and irrevocable unilaterally, the manufacturer loses practical control of the file.
• Express every external commitment on timelines and fees as a practical estimate. The figures 8–24 months and IQD 500,000–15,000,000 previously shown on the GRZAN website were not found in any Iraqi official regulation or government announcement in this review; they are practical-range estimates, and the actual figures follow official notice at acceptance.
• The Kurdistan Region has an independent health-authority system; this article describes the federal (Baghdad) level only.

5. Verification checklist

• □ Request the current company registration application form and document list from the Registration Department (DTA) and confirm whether device-company registration still follows the 6-item document list.
• □ Obtain gazette originals of the Scientific Bureau Instructions No. 4 (1998) and the Pharmacists’ Practice Law No. 40 (1970) and check article numbers and wording.
• □ Check the list of certificate of incorporation, articles of association and power of attorney required by Article 10 of Instruction No. 1 of 2025.
• □ Re-check §§6.4 and 6.5 of the Pharmaceutical Country Profile 2020 and confirm that the five-year wording is an information review cycle, not a certificate validity period.
• □ Where the client is already attached to an agent, obtain the original power of attorney and check its term, revocation right and file-ownership clauses.
• □ Re-check whether the official documents cited here have been replaced by later instructions or decisions (verification baseline date: 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 coordinates local importer arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com