Ministry of Health · structured requirements

🇮🇶 Iraq IVD regulatory data

Explore the IVD requirements currently available for Iraq, organized by topic and linked to official sources.

1 facts1 dimensions1 official sourceslatest verification 2026-09-15

Changes after registration in Iraq

Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

A source-verified answer for this specific scenario is not yet published.

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

A source-verified answer for this specific scenario is not yet published.

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

A source-verified answer for this specific scenario is not yet published.

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

A source-verified answer for this specific scenario is not yet published.

Can a registration transfer to a different legal entity?

A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.

A source-verified answer for this specific scenario is not yet published.

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

A source-verified answer for this specific scenario is not yet published.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Iraq approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Iraq (3 records)

IraqNMPA

Regulatory reference

KIMADIA 2023 dialysis tenders: specified FDA/CE evidence, not a national registration rule

reliance.china-nmpa-not-reference

Pending verification

Statement: KIMADIA tenders 55/2023/84 and 55/2023/85 for the national hemodialysis project specify FDA/CE quality evidence for the covered equipment. This dated tender document does not establish the requirements of every Iraqi procurement or private-sector registration. Its Arabic/English wording also differs at item 2, so the procurer should resolve the exact tender requirement.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: iraq
China Classes In Scope: Equipment covered by these two 2023 dialysis tenders only
Edge Type: Eligibility Unresolved
Market Access Strength: undetermined
Regulatory Layer: Public Procurement
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Historical tender-specific evidence; current procurement and private-market requirements are unconfirmed.
Do not generalise this tender to all medical devices or IVDs in Iraq.
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Source passage: على ان تكون الاجهزة حاصلة على شهادات (FDA or CE) ومصنعة من قبل شركات عالمية رصينة وحسب المواصفات الفنية المعتمدة من قبل دائرة الامور الفنية / قسم ادارة الاجهزة الطبية ... 34- تكون الاجهزة الطبية الاساسية والملحقة والاجهزة المختبرية حاصلة على شهادة الجودة (FDA or CE).

IraqUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Origin-market evidence expected in practice; no published period reduction

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"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

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IraqEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority: EU CE Mark
Accepted: Yes
Benefit: Origin-market evidence expected in practice; no Iraqi instrument on a reachable source grants an abridged period for it

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"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

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Related structured datasets

Classification systems · 0 records

No maintained record.

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Iraq registration →

Country

Iraq

Jurisdiction Id

iraq

Country Code

IQ

Flag

🇮🇶

Regulator

Ministry of Health — Technical Affairs Directorate (دائرة الأمور الفنية), with the National Center for Drug Control and Research

Regulator Abbrev

Ministry of Health

Region

middle-east

Tier

3

Risk Classification

No published Iraqi risk-class rule for medical devices; the evaluation service is scoped by product family, not by class

Classes

Id
laboratory-device-evaluation
Class Name
Laboratory devices, materials and supplies (الاجهزة والمواد والمستلزمات المختبرية) — all classes
Pathway
MoH Technical Affairs evaluation via the UR national services portal
Official Timeline
Min
10
Max
10
Unit
working-days
Verification Status
official-verified
Official Source
Title
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"
Url
https://ur.gov.iq/index/show-eservice/51503/10035/cat
Accessed Date
2026-08-30
Realistic Timeline
Min
1
Max
4
Unit
months
Notes
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
Filing is restricted to companies, scientific offices and government bodies such as Kimadia (الشركة العامة لتسويق الادوية والمستلزمات الطبية); an individual manufacturer cannot file
The output is an evaluation of fitness for use, not a registration certificate, and the fee is set on a separate schedule linked from the service page
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No

Prior Approvals

Authority
EU CE Mark
Accepted
Yes
Benefit
Origin-market evidence expected in practice; no Iraqi instrument on a reachable source grants an abridged period for it
Authority
FDA 510(k)
Accepted
Yes
Benefit
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

Local Rep Required

Yes

Local Rep Name

Iraqi registered company or scientific office (مكتب علمي)

Mdsap Accepted

No

Mdsap Benefit

Not recognized

Registration Validity

Not published; the import licence is valid one year from issue

Last Updated

2026-08-30

Verification Status

partially-verified

Official Sources

Title
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"
Url
https://ur.gov.iq/index/show-eservice/51503/10035/cat
Accessed Date
2026-08-30
Title
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
Url
https://ur.gov.iq/index/show-eservice/51307/10035/cat
Accessed Date
2026-08-30

Reviewed On

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Health. Appoint a Iraqi registered company or scientific office (مكتب علمي).
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
Ministry of Health reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. Ministry of Health may issue questions.
Duration
10 working days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, Ministry of Health issues Iraq market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Iraq fees →

Jurisdiction Id

iraq

Country

Iraq

Country Code

IQ

Authority

Ministry of Health

Low Risk Local

Min: 1000
Max: 1000
Currency: IQD
Per Product: No

High Risk Local

Min: 20000
Max: 20000
Currency: IQD
Per Product: No

Details

Id
krg-device-permit-form
Item
KRG device permit application form
Currency
IQD
Amount Local
1000
Amount Local Formatted
IQD 1,000
Frequency
Per application
Notes
Kurdistan Regional Government procedure.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://services.gov.krd/ar/service/moh-33-ar
Source Title
KRG KMCA import-permit fees (administrative decision 4527/2014)
Verified On
2026-08-25
Id
temporary-import-permit
Item
Temporary import permit
Currency
IQD
Amount Local
20000
Amount Local Formatted
IQD 20,000
Frequency
Per permit
Notes
KRG procedure.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://services.gov.krd/ar/service/moh-33-ar
Source Title
KRG KMCA import-permit fees (administrative decision 4527/2014)
Verified On
2026-08-25

Notes

These two published amounts apply only to the cited Kurdistan Regional Government procedures and must not be presented as federal Iraqi registration fees.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
KRG KMCA import-permit fees (administrative decision 4527/2014)
Url
https://services.gov.krd/ar/service/moh-33-ar
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Iraq certifications →

Slug

iraq

Market

Iraq

Confidence

low

Schemes

Id
cosqc-import-inspection-and-pre-shipment-inspection
Name
COSQC import inspection and pre-shipment inspection
Category
Import Conformity
Status
Mandatory At Import
Object
Imported Shipment
Note
No device-specific mandatory certification scheme (CE/FDA/ISO 13485 market requirement) was located for federal Iraq; import-control overlays apply: COSQC standards, import sample examination and pre-shipment inspection (Law 54/1979).
Source Urls
https://mop.gov.iq/%D8%A7%D9%84%D8%AC%D9%87%D8%A7%D8%B2-%D8%A7%D9%84%D9%85%D8%B1%D9%83%D8%B2%D9%8A-%D9%84%D9%84%D8%AA%D9%82%D9%8A%D9%8A%D8%B3-%D9%88%D8%A7%D9%84%D8%B3%D9%8A%D8%B7%D8%B1%D8%A9-%D8%A7%D9%84%D9%86%D9%88
Source Binding
reviewed
Id
radioactive-source-authorization
Name
Radioactive-source authorization
Category
Ionizing Radiation
Status
Mandatory If Feature
Object
Device Containing Radioactive Source
Note
Devices containing radioactive sources require authorization from the National Authority for Nuclear, Radiological, Chemical and Biological Control.
Source Binding
unresolved

Official Sources

Authority
Iraq Ministry of Planning (COSQC)
Topic
import inspection and pre-shipment inspection programme; radioactive-source authorization
Url
https://mop.gov.iq/%D8%A7%D9%84%D8%AC%D9%87%D8%A7%D8%B2-%D8%A7%D9%84%D9%85%D8%B1%D9%83%D8%B2%D9%8A-%D9%84%D9%84%D8%AA%D9%82%D9%8A%D9%8A%D8%B3-%D9%88%D8%A7%D9%84%D8%B3%D9%8A%D8%B7%D8%B1%D8%A9-%D8%A7%D9%84%D9%86%D9%88

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Need to apply Iraq's requirements to a product?

Confirm the current Ministry of Health pathway, evidence, and local-role details for the actual device before filing.