BDS Point 8: Production Site Registration for Medical Equipment Tenders

1. Key takeaways

This hard deadline has already passed. On January 21, 2025, the State Company for Marketing Drugs and Medical Appliances (KIMADIA) published circular No. 48556, on company registration, on its official website, with an attached PDF adding a registration clause to point 8 of the Bid Data Sheet (BDS) of the standard tender documents: companies of medical and service equipment must register their production sites by December 31, 2025, after which unregistered companies will not be allowed to participate in tenders of medical and service equipment. Measured against the baseline date of this article, the deadline has lapsed, and companies that have not completed the registration are eliminated at the qualification review stage.

• The clause was added to point 8 of the Bid Data Sheet of the standard tender documents, announced by KIMADIA circular No. 48556.
• Deadline: production sites of medical and service equipment companies must be registered by December 31, 2025.
• Consequence: after that date, unregistered companies are excluded from tenders of medical and service equipment.
• The requirement is not limited by nationality; the wording refers to medical and service equipment companies, and no extension notice was found on the KIMADIA website up to the baseline date.

2. Legal basis

The table below lists the sources cited in this article together with their document numbers, publication dates and the provisions relied upon.

Source grading: the KIMADIA circular is graded primary and verified (published on kimadia.gov.iq; the PDF was downloaded and its full text extracted; the PDF page itself bears no issuing body or date, the date of January 21, 2025 being taken from the website posting page). The Instructions on the Execution of Public Contracts No. 1 of 2025 are graded primary and verified (the gazette original was downloaded from the Planning Ministry’s domain at https://mop.gov.iq/documents/gov_contarct/instructions/2025.pdf).

Excerpts of the original provisions:

• Arabic original: approval was granted to add a clause on the registration of medical and service equipment companies within the standard tender documents, in the Bid Data Sheet, point 8, providing that such companies must register their production sites by December 31, 2025, after which unregistered companies will not be permitted to enter tenders of medical and service equipment.
• English counterpart original: «(medical & service companies should register their production sites until 31/12/2025, after that unregistered companies will not be allowed to participate in tenders of medical & service equipment)»
• Correspondence: point 8 works together with the Instructions on the Execution of Public Contracts No. 1 of 2025, the parent law of the tendering procedure; Article 41 of the 2025 Instructions repeals Instructions No. 2 of 2014, which continue to apply only to contracts concluded under them — all old drafts citing No. 2 of 2014 must be revised accordingly.

3. Expert insights

Insight 1 | This is the hard deadline most overlooked by Chinese companies in recent years, because it is a clause in a tender document rather than a statute. It appears in no statutory search and in few Iraq registration guides; it was published as a one-page PDF by KIMADIA, embedded in the standing text of the standard tender documents. Companies discover at qualification review, when downloading the tender file, that they fail the check — too late, since the registration itself takes time.

Insight 2 | Cross-border comparison: the Iraqi version of the internationally common production site registration. Egypt’s EDA and Saudi Arabia’s SFDA run similar plant and production site registration schemes, generally requiring completed registration before bidding; the US FDA operates Establishment Registration and Device Listing with annual renewal, and the products of unregistered establishments may not enter interstate commerce. Iraq follows the same logic: the object is refined from the company to the production site, and multi-site manufacturers may need to register each site separately.

Insight 3 | Debunking: the two circulating claims that the deadline has been extended and that it applies only to local companies were found in no directly reachable official channel; since the KIMADIA website was reachable this round, this negative finding carries real weight and amounts to a substantive refutation. The original circular uses the phrase companies of medical and service equipment, with no restriction of nationality; up to the baseline date, no extension notice appeared on the posting page or in subsequent circulars. On hearing such claims, demand the Arabic circular title and the posting date.

Insight 4 | It turns company registration and site registration into two separate acts. The six items of the Registration Department discussed in article 12 of this series are company registration; this clause requires production site registration. Companies that conflate the two present the Registration Department’s documents at public tenders and are then found at qualification review to lack the site registration.

Insight 5 | The position at point 8 of the Bid Data Sheet is worth remembering. The BDS is the project-level parameter sheet of the standard tender documents, generated afresh for every tender announcement. Writing the clause into the pre-set BDS text makes it appear automatically with every tender file. The obligation has therefore become a standing clause: missing the window of that year does not make the requirement disappear — it becomes the default value in every tender document.

4. Practical recommendations

• Check immediately whether the medical and service equipment tenders the company intends to enter require production site registration already completed; where not, confirm the remediation path and transitional arrangements with KIMADIA and keep the written reply.
• Multi-site manufacturers should apply one-to-one mapping: register the site where the products are actually made, and ensure the registration documents and the exported products can be matched to each other.
• Maintain a periodic review list: search the KIMADIA website announcements every quarter, focusing on whether point 8 of the Bid Data Sheet has been rewritten or given new deadlines.
• Within 24 hours of downloading a tender file, complete a gap analysis of the qualification clauses: map each point of the BDS to existing documents and open a project immediately for any missing item.
• Practical estimate: remedial registration typically takes from several weeks to several months until the certificate is actually obtained (no official provision found); plan tendering backwards and never start the paperwork at the closing date.

5. Verification checklist

• □ Download the KIMADIA website post No. 48556 (posting date January 21, 2025) and check the Arabic original and the wording of point 8 of the BDS.
• □ Search all KIMADIA circulars published after that posting and confirm whether any extension, exemption or refinement of the registration procedure has been notified.
• □ Download the Bid Data Sheet of the latest medical and service equipment tender announcement and confirm whether the text of point 8 has been updated.
• □ Check whether the production address in the company’s ISO 13485 certificate and registration documents matches the site to be registered.
• □ Ask the relevant KIMADIA department in writing about the remediation path for unregistered companies and whether they are listed as barred from tendering.
• □ Check Article 41 of the Instructions on the Execution of Public Contracts No. 1 of 2025 and confirm that the legal basis of tender documents is the 2025 version, not No. 2 of 2014.
• □ Re-verify whether the official documents cited in this article have been replaced by subsequent instructions or resolutions (verification baseline date of this article: October 29, 2026).

Regulatory information verified as of October 29, 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 federal and Kurdistan registration applications, prepares reference-country dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com