Iraq medical device registration timeline

Source-linked clocks

Ministry of Health — Technical Affairs Directorate (دائرة الأمور الفنية), with the National Center for Drug Control and Research (MoH) review clocks and end-to-end planning ranges, using the No published Iraqi risk-class rule for medical devices; the evaluation service is scoped by product family, not by class classification system.

1 pathways1 of 1 clocks verifiedvalidity Not published; the import licence is valid one year from issueMDSAP not acceptedreviewed 2026-08-30ur.gov.iq

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Laboratory devices, materials and supplies (الاجهزة والمواد والمستلزمات المختبرية) — all classes(MoH Technical Affairs evaluation via the UR national services portal) The service page states وقت إنجاز الخدمة: (10) ايام عمل كحد اقصى — ten working days maximum, which is the only numeric device clock Iraq publishes	10 working days	1-4 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Iraq Medical Device Registration Process

Step-by-step MoH registration process. Total estimated timeline: 1-4 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by MoH. Appoint a Iraqi registered company or scientific office (مكتب علمي).

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to MoH including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

MoH reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

10 working days

In-depth technical assessment of device safety and performance. MoH may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, MoH issues Iraq market authorization certificate.

Summary: The Iraq medical device registration process through Ministry of Health — Technical Affairs Directorate (دائرة الأمور الفنية), with the National Center for Drug Control and Research (MoH) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

EU CE MarkOrigin-market evidence expected in practice; no Iraqi instrument on a reachable source grants an abridged period for it

FDA 510(k)Origin-market evidence expected in practice; no published period reduction

Key requirements

A UR national portal account is a precondition for the laboratory-device evaluation service
Applications are filed by a registered company, scientific office or government body, not by the foreign manufacturer directly
Medical equipment and supplies require a Ministry of Trade import licence before customs clearance, under Customs Law No. 23 of 1984 Art. 27(3)
Verified negative on the product-registration clock: the Ministry of Health portal sits behind a challenge gateway and the National Center for Drug Control and Research site is offline, so no registration period could be confirmed from an official source

Primary regulator sources

ur.gov.iq · بوابة أور — تقديم طلب إلكتروني لتقييم الاجهزة والمواد والمستلزمات المختبرية (Iraq UR national services portal, service 51503, Ministry of Health Technical Affairs Directorate): "وقت إنجاز الخدمة (10) ايام عمل كحد اقصى" ur.gov.iq · بوابة أور — إجازة الاستيراد (Iraq UR national services portal, service 51307): medical equipment and supplies require an import licence, valid one year from issue, with no completion time published

Reviewed 2026-08-30. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against MoH publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:iraq:laboratory-device-evaluation