🇮🇶 Iraq medical device regulatory data

Federal Iraq: Ministry of Health (MOH); its Technical Affairs Directorate (دائرة الأمور الفنية) houses the Registration Department (قسم التسجيل — companies, preparations, scientific offices) and the Medical Devices Management Department; KIMADIA, the MOH state company for marketing drugs and medical appliances, executes public-sector import of devices. The Kurdistan Region runs a separate KRG MOH structure (KMCA).

The Central Organization for Standardization and Quality Control (COSQC, الجهاز المركزي للتقييس والسيطرة النوعية), established by Law No. 54 of 1979 (amended), is Iraq's central body for measurement standards, calibration references and Iraqi quality standards, under the Ministry of Planning; it inspects imported goods and monitors the quality of local products.

The Medical Devices Management Department (قسم إدارة الأجهزة الطبية) within MOH Technical Affairs Directorate provides technical specifications and consulting and follows up medical devices across the ministry — including follow-up with health directorates on installation, warranty and maintenance, maintaining a detailed statistical database of devices, and testing/evaluating device performance and their need for calibration and periodic maintenance. Market registration of devices is not among its listed duties.

KIMADIA (State Company for Marketing Drugs and Medical Appliances, founded 1964) is the MOH public company whose functions include taking the necessary measures to import and market Iraq's needs of medicines, scientific appliances, medical and service devices and their spare parts; it is the operational public-procurement import channel for devices.

In the Kurdistan Region of Iraq, import licenses for medical devices and materials are issued by the Directorate of Drug and Medical Device Import and Production (KMCA, Erbil) under the KRG Ministry of Health — a structure separate from the federal MOH.

The MOP standard bidding document for medical equipment defines 'Registration Certificate' as the certificate of registration (or other documents in lieu) establishing that the medical appliances supplied under the contract are registered for use in Iraq in accordance with the Applicable Law; 'medical appliances' is a tender-defined term for the equipment listed in the Schedule of Requirements.

Pharmaceutical company and manufacturing-site registration files with MOH include, among other documents, a GMP certificate, a manufacturing licence, a Site Master File and a boycott declaration (اقرار مقاطعة مع اسرائيل).

For goods supplied from outside Iraq under the MOP standard contract, the supplier must deliver with the shipment: signed and stamped invoice; transport document to final destination; packing lists; insurance certificate showing the Purchaser as beneficiary; one original manufacturer's or supplier's warranty certificate covering all items supplied; certificate of origin endorsed by the relevant Iraqi commercial agencies abroad; and, where inspection is required, the original Certificate of Inspection from the nominated inspection agency.

For pharmaceutical company and manufacturing-site registration with MOH, the manufacturer's authorization must be issued in the name of the scientific office or the authorized person inside Iraq; foreign pharmaceutical manufacturers therefore act through a scientific office or authorized person established in Iraq.

The KRG import license for medical devices and materials (issued by KMCA) requires a certified certificate of origin, a packing list, the purchase invoice, and a copy of the packaging artwork; the service condition references company registration at the KRG Ministry of Health.

Companies and scientific offices importing radioactive sources must first obtain an import authorization for radioactive sources from the National Authority for Nuclear, Radiological, Chemical and Biological Control, and then obtain the import license through the Ministry of Trade / General Company for Iraqi Exhibitions and Commercial Services.

Under Iraq's Ministry of Planning standard bidding document for the purchase of medical appliances, the supplier's marking and documentation duties on the goods are set by the contract itself, not by a fixed national label-content rule: the packing, marking and documentation within and outside the packages must comply strictly with such special requirements as shall be expressly provided for in the Contract, including additional requirements, if any, specified in the Special Conditions of Contract (SCC) or the Technical Specifications, and in any subsequent instructions ordered by the Purchaser.

COSQC's legal basis is Law No. 54 of 1979 (amended) covering standards, metrology and quality control; its metrology department also applies the Weights and Measures Branding Law No. 42 of 1978 (amended).

KIMADIA is governed by the Public Companies Law No. 22 of 1997 (as amended) and its Rules of Procedure No. 1 of 1999.

Public procurement of medical equipment in Iraq uses Ministry of Planning standard bidding documents (الوثائق القياسية); a dedicated standard document for purchasing medical equipment is published (2024) in Arabic, English and combined versions, alongside documents for medical supplies, laboratory supplies and medicines/vaccines.

The MOH Medical Devices Management Department's follow-up duties include maintaining a detailed statistical database on the numbers of medical devices in MOH facilities and working to test and evaluate device performance and their need for calibration and periodic maintenance; it also follows up devices with the health directorates regarding installation, warranty and maintenance.

Under the MOP standard contract, supplier obligations include installation, demonstration and on-site training at end-user sites (priced in the schedule), keeping sufficient stock of required spare parts, and an annual 'UPTIME' warranty percentage (e.g. 95% or 98%) with annual-maintenance-contract extension as the remedy during the AMC period.

KRG device import license applications are submitted online via erequest.kmcakrg.org (the type of materials is selected in the request); after electronic approval, fees are paid at the KMCA accounts section, the permit is printed at the printing section, and the file is received from the relations section.

Scientific offices must complete the 'scientific offices information accreditation form' (نموذج اعتماد معلومات المكاتب العلمية) so that data is collected and migrated into the Registration Department's electronic system; the office's account is activated after registration.

Iraq's standard bidding document for medical appliances gives the Purchaser or its representative the right to inspect and/or to test the medical appliances to confirm their conformity to the Contract specifications. The Special Conditions of Contract and the Technical Specifications must state what inspections and tests the Purchaser requires and where they are to be conducted, and the Purchaser must notify the Supplier in writing, in a timely manner, of the identity of any representatives retained for those purposes. GCC Clause 9.2 makes the article subject to what is specified in the SCC.

COSQC's remit includes limiting the inflow of low-quality goods by inspecting imported goods and monitoring the quality of local products (market surveillance under Law 54/1979).

If the successful bidder's medical appliances are not registered in Iraq at the time of contract signing, the contract becomes effective only on the date the Certificate of Registration is obtained; the Minister of Health may exclude the successful bidder from submitting the registration certificate upon signing, in which case the contract is valid; the Contracting Entity must at all times cooperate to facilitate registration (ITB 7.4.1).

The Registration Department (قسم التسجيل) within MOH Technical Affairs Directorate handles registration of companies and (drug) preparations and accreditation of scientific offices, with the processes being automated into an electronic system.

KIMADIA announced that approval was obtained to add a clause to the model tender documents (Bid Data Sheet point 8) requiring medical and service equipment companies to register their production (manufacturing) sites by 31/12/2025, after which unregistered companies will not be allowed to participate in medical and service equipment tenders.

Under the MOP standard bidding document (ITB 7.4): unless the Bid Data Sheet stipulates otherwise, the medical appliances to be supplied under the contract must be registered with the competent authority in Iraq; a bidder already holding registration submits a copy of the Registration Certificate with its bid, and otherwise the successful bidder must submit at contract signing either the certificate or evidence of compliance with all documentary registration requirements specified in the Bid Data Sheet; exclusion from registration is permissible under the Minister of Health's powers.

COSQC examines samples of imported goods referred by the General Customs Authority, the Ministry of Health and other ministries; it operates a pre-shipment inspection and testing program before supply in the country of origin or export, and runs a dedicated conformity-assessment department for imported goods (قسم تقويم المطابقة للسلع المستوردة).

For a medical-appliance supply contract awarded in Iraq, the Contracting Entity must respond immediately and in writing to any bidder who submits an inquiry to the contracting authority about the reasons for not choosing its bid, after receiving notification of the award decision. The notification of award forms the contract only subject to settlement of an unsuccessful bidder's appeal, and the mechanism used in considering bidders' complaints is the instructions for the implementation of the general government contracts in force. The Contracting Entity sends the contract form only after the standstill period and settlement of appeals, and where an appeal is pending it still has the right to proceed with the successful bidder upon finding that the contract is fully compliant and that it is in the public interest not to delay commencement.