Approved Entry Points for Medicines and Medical Supplies: Arar and Zurbatiyah

Updated: 2026-11-11 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

A KIMADIA announcement of April 2026 states that the Arar crossing on the Saudi border and the Zurbatiyah crossing on the Iranian border have been approved for the entry of medicines and medical supplies. It confirms device entry through approved crossings and gives the first occurrence in a primary official document of the term for medical supplies. One warning: the announcement does not exclude other crossings, so it cannot be read as restricting entry to these two. Moreover, the federal level and the Kurdistan Region are two different control forms: the federal side offers an approved-crossings list; on the Kurdistan side, under Article 3(2) of Instruction No. 1 (2016), border crossings must not release any materials without the consent of the Region Ministry of Health’s Quality Control Directorate for Drugs, Consumables and Medical Devices (KMCA) — case-by-case prior consent.

  • Arar and Zurbatiyah are approved crossings for medicines and medical supplies.
  • Approval is not exclusivity: other crossings are not excluded by the text.
  • Federal control is list-based and self-checkable; Kurdistan Region control is per-shipment prior KMCA consent.
  • The border crossing is a mandatory field of the advance customs declaration and locks after remittance.

2. Legal basis

The instruments below carry the crossing approval and the two control forms. Verification status follows the source review.

KIMADIA announcement approving entry crossings for medicines and medical suppliesUnnumbered website announcement; published 2026/04 (website publication month); one paragraph, no article numbers.
Cabinet Decision No. 569 (2025)Adopted 2025-07-22, in force 2025-12-01; point 2 of the decision points (the advance declaration must state the border crossing).
Kurdistan Region Instruction No. 1 (2016) on clearance pre-approval and device accessArticle 3(2) (customs clearance prior approval); Article 9(7)(a) (devices not subject to import licence, entry permit instead) — primary, verified (rasterised photocopy read verbatim, reading completed to page 7, language Sorani Kurdish).

Source levels and reading boundary. The announcement is primary and verified; its PDF carries no date, and the date follows the website publication month. Decision 569 is primary and verified. The Kurdistan instruction is primary and verified as far as read — a 24-page scan, pages 1 to 7 read verbatim in Sorani Kurdish; nothing beyond the read pages is asserted.

Extracts of the operative provisions. The announcement approves Arar and Zurbatiyah for entry of medicines and medical supplies. Point 2 of Decision 569 makes the border crossing a mandatory field of the advance declaration. The instruction names the Quality Control Directorate for Drugs, Consumables and Medical Devices (KMCA) within the Kurdistan Region Ministry of Health — a directorate inside the ministry, not an independent authority. Article 9(7)(a): medical devices, medical services and their supplies are not subject to the import licence (devices are not product-registered in the Region) but require an entry permit issued by KMCA. Article 3(2), on the reading completed in this review: no border crossing may release any materials without the consent of KMCA.

Further figures within the read pages (1–7): shelf-life consumed at arrival must not exceed 50%; free samples must not exceed 10% of the annual application volume; first violations draw a one-month warning, continued or repeat violations draw suspension. (Pages 8–24 unread.)

3. Expert insights

Both official Arabic terms must be used; choosing one loses half the record. Article 01 shows that Iraq’s federal Public Health Law No. 89 (1981), in all 106 articles, contains no regulatory device definition. Official documents use two terms side by side: this announcement uses medical supplies, while KIMADIA tenders also use medical devices, as in the notice of 2025-01-21 for medical device and service companies. GRZAN keeps both in parallel with sources — choosing one drops half the search hits.

Approval does not mean exclusivity. The announcement’s verb is approval, not restriction. Reading it as only these two crossings converts approval into exclusivity. GRZAN requires the crossing to be treated as a variable confirmed per shipment, not a fixed parameter.

Federal versus Kurdistan Region: two control forms that must not be conflated. The federal announcement offers an approved-crossings list: besides Arar and Zurbatiyah, it records a new unit at Kirkuk International Airport — the wording is establishing a unit, not approving Kirkuk airport as a medicines and devices entry port. Checking against a list is list-based control, which still does not exclude other crossings. The Region side differs entirely: under Article 3(2) of Instruction No. 1 (2016), no border crossing may release any materials without KMCA consent. There is no list to check by oneself; release depends on that shipment first obtaining KMCA consent. The difference is the control point: a public list the company checks, versus per-shipment consent applied each time. With Article 9(7)(a), devices in the Region follow the KMCA-issued entry permit, so crossing release for devices is wrapped inside that precondition. GRZAN’s rule: the two sides run their own channels.

The crossing field is a hard coupling easily overlooked. Decision 569 (article 35) requires the declaration to state the border crossing, and this announcement shows crossings must be approved: a field fixed before remittance and consistent with the approved list, not decided by the broker on the spot. Fill it wrong, and — under point 7 of article 35 — it cannot be corrected after remittance.

Threaded together, the articles form one operating chain. Article 30 fixes classification, article 34 the duty, article 35 the declaration lock, this article the crossing, article 36 the prepayment and release check; a change in one link flows back to the previous — hence GRZAN’s single ledger instead of three suppliers.

4. Practical recommendations

  • List the entry crossing as a written clause in the contract and logistics plan, checked per shipment against the latest approved list. Practical estimate: no official provision was found on list update frequency.
  • Keep the border crossing field consistent with the logistics plan and the commercial invoice, checked before remittance.
  • For transiting or land routes, confirm in advance whether transit affects the origin and shipment-country fields, which interlock with the crossing field.
  • Do not treat the announcement as fixing the crossings: client documents state the currently approved crossings include Arar, Zurbatiyah and the new unit at Kirkuk International Airport, subject to the latest announcement before shipment — include, never limited to.
  • Kurdistan Region projects cannot reuse the federal approach: under Article 3(2) of Instruction No. 1 (2016), per-shipment prior consent must be obtained from KMCA (for devices, the entry permit), scheduled separately. Responsible parties: the Region-side importing entity and the GRZAN regulatory team; timing: federal side before remittance, Region side before each shipment. Practical estimate: processing time for per-shipment consent not found in the pages read (pages 1–7; 8–24 unread).
  • Combine with the remittance preconditions of article 35: document preparation, crossing confirmation and classification confirmation all completed before remittance.

5. Verification checklist

  • □ Search the KIMADIA website announcements for the original 2026/04 crossing approval and check the Arabic wording and publication month.
  • □ Confirm the announcement’s verb is approval and that no exclusivity wording appears (no restriction, limitation or only).
  • □ Re-check point 2 of Decision 569: the border crossing is a mandatory field of the advance declaration.
  • □ Cross-check with point 7 of article 35 (no modification after remittance) the locking consequence for the crossing field.
  • □ Before shipment, re-check with KIMADIA or the local agent whether the approved crossings list has been updated.
  • □ Re-check the Kirkuk International Airport wording (establishment of a unit); external documents must not state Kirkuk airport was newly approved as an entry port.
  • □ Complete the reading of pages 8–24 of the Kurdistan Region Instruction No. 1 (2016), searching for crossing-related provisions beyond Article 3(2) and Article 9(7)(a).
  • □ Confirm in writing with KMCA the application materials, processing time limit and issuance process of the per-shipment prior consent and the entry permit.
  • □ Cross-check with articles 30, 34 and 36 that classification, duty, documents and crossing are consistent for the same consignment.
  • □ 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

Disclaimer

Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.

About GRZAN

GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.

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