Federal Iraq Versus the Kurdistan Region: Two Registration Tracks

1. Key takeaways

Iraq is not one system but two running in parallel, the federal system (Baghdad) and the Kurdistan Region (KRG, Erbil); the difference is not procedural speed but regulatory status itself. The Region’s Ministry of Health catalogue lists item MOH-33, medical device import licence (import of devices and medical materials); on the federal side the corresponding terms are the federal devices term and the Article 3 item 11 medical supplies term. Devices are an independent declared category in the Region (Administrative Decision Record No. 4527, 2014-05-25; Instructions No. 1 of 2016), an independent fee entry (amount to be verified with the accepting window). Under Article 9, seventh paragraph (a), of Instructions No. 1 of 2016, devices are not subject to the import licence and instead take a KMCA entry permission. Federal official statements on the national drug traceability and electronic labelling system concern drugs; no statement was found covering devices or supplies.

• Two parallel systems: federal (Baghdad) and Kurdistan Region (KRG, Erbil), differing in regulatory status, not speed.
• MOH-33 covers device import in the Region; sources are Administrative Decision Record No. 4527 (2014-05-25) and Instructions No. 1 of 2016.
• Devices take an entry permission from KMCA under Article 9 seventh paragraph (a), not the import licence.
• Federal traceability statements cover drugs only; no device or supplies coverage was found.

2. Legal basis

The instruments relied on:

Source grade. Region MOH-33: primary, verified (catalogue page, undated; source numbers and dates from the catalogue; wording to recheck against the original page). Instructions No. 1 of 2016, Article 9 seventh paragraph (a): primary, verified by verbatim reading of the facsimile. Federal side: statements by a named official plus media relay, no official decision number; never cite as article X of Iraqi regulation. Public Health Law: primary, verified.

Reading boundary. Instructions No. 1 of 2016 was read through page 7 only (pages 8–24 not reviewed); coverage judgments must stay within this boundary.

Excerpts:

• Region (Article 9 seventh paragraph (a), Sorani original): devices and medical services with their supplies are not subject to the import licence, devices being not registered; they require a KMCA entry permission.
• Region (KMCA full title, Kurdish original): the Quality Control Directorate for Drugs, Supplies and Medical Devices (KMCA) within the Ministry of Health.
• Federal (official’s statement): any product that does not pass the required inspection cannot receive the official label.
• Region (department statement, media relayed, no official decision number): drugs and medical supplies without quality control labels from the ministry of health are deemed illicit and contraband.

Labelling and licensing comparison (blanks are written as not found, never guessed):

3. Expert insights

Insight 1: the Region lists devices as an independent declared category; the federal side does not — the most substantive difference. Common write-ups reduce the difference to procedure and speed, but the Region has an independent device service item with traceable legal sources; no federal counterpart was found this time.

Insight 2: the Region’s sources are traceable, the federal side’s are not; the contrast is the method. The Region gives two verifiable numbers, the Administrative Decision Record No. 4527 of 2014-05-25 and Instructions No. 1 of 2016; the federal traceability system has no published official decision number, only a named official’s media-relayed statements.

Insight 3: why we do not give a fee figure. The catalogue lists devices as an independent fee entry, but the page shows no legible amount; the only visible fee items were 1,000 dinars (form fee) and 20,000 dinars (temporary import licence, limited to herbal items, food supplements, and sterile materials). Any figure called the Region’s device import licence fee has no primary source this time; the amount goes in the checklist, not the pricing model.

Insight 4: the item is named import licence, but the instrument says devices do not fall under it; where they conflict, the legal source prevails. Article 9 seventh paragraph (a) states that devices and their supplies are not subject to the import licence, devices in the Region being not product-registered; they take the entry permission issued by KMCA, within the Region’s Ministry of Health. The catalogue is portal-level; the instrument is legal-source-level and prevails.

Insight 5: the Region expressly accepts English, and its labelling position is stricter; a blanket Arabic-mandatory claim cannot stand. Article 4, second paragraph requires essential packaging and instructions information in at least one of Kurdish, Arabic, or English; the per-batch certificate of analysis, analysis methods, and quality specifications may be filed in English. Federal side: no official provision mandating Arabic was found; Region side: three languages, one of which suffices, is explicit. The federal side covers drugs only — the Region is stricter.

4. Practical recommendations

• Treat entering the Kurdistan Region as a mandatory question at project start, not a pre-shipping logistics option.
• Region projects: check four items against the catalogue (declared category, source number, fee standard, application materials); devices go through the entry permission, not the import licence. Practical estimate: no official provision on catalogue update frequency was found.
• Federal projects: carry buffer for the unsearchable official position and schedule the recheck. Practical estimate: buffer length is a GRZAN recommendation (no official provision found).
• Prepare labelling to the Region standard, covering both the drugs and the medical supplies wording.
• Where one client covers both, issue two separate compliance checklists; never assume one dossier serves both.
• Schedule Region entity registration and premises to the instrument thresholds: company registration renewed every 2 years, office of at least 60 m², warehouse of at least 200 m².

5. Verification checklist

• □ Locate MOH-33 in the Region MOH catalogue; verify the Arabic item name and source column verbatim and the sources: Administrative Decision Record No. 4527 (2014-05-25) and Instructions No. 1 of 2016.
• □ Confirm devices are an independent fee entry; verify the amount with the accepting window (none obtained this time).
• □ Verify the wording of Article 9 seventh paragraph (a) and Article 4 second paragraph (one of three languages).
• □ Record the reading boundary: read through page 7; pages 8–24 not reviewed.
• □ Confirm whether device-related service items exist beyond MOH-33.
• □ Federal: search for the traceability system’s official decision number and effective date (not obtained this time).
• □ Verify the source of the Region’s drugs and medical supplies department statement (media relayed, no decision number).
• □ Cross-check wording against Article 01 and the linked series article.
• □ Recheck whether the documents cited here have been superseded (verification 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 manages KMOC (Kurdistan) and federal MOH registration procedures, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com