Free Sale Certificates Are Not in the Official Checklist

1. Key takeaways

The Certificate of Free Sale (CFS) is not among the six registration items the Iraqi Registration Department requires from device companies. According to the Drug Registration Regulations published by the Registration Department of the Technical Affairs Directorate of the Iraqi Ministry of Health, the six items of Section D are, in order: the company registration form, the quality assurance system certificate, the officially legalized manufacturer registration certificate of the country of origin, the product data sheet or catalogue, the Israel boycott certification letter, and the company registration fee of USD 1,000 — the phrase Certificate of Free Sale never appears. The document expressly subject to three-tier legalization (Ministry of Health, Ministry of Foreign Affairs, and the Iraqi embassy in the country of origin) is the pharmaceutical product certificate (CPP) in Section E item 2, within the pharmaceutical registration requirements. The circulating claim that devices must submit a CFS is found only on service-provider lists. As of October 29, 2026, no official provision supporting that claim was found in any legally reachable official channel or officially hosted library; because the Ministry of Health website, the Ministry of Justice and the official legal database were unreachable, this conclusion must not be presented as a claim that Iraq has no CFS requirement.

• The Section D list contains six items and no CFS; the free-sale wording appears only inside the pharmaceutical CPP clause of Section E item 2.
• The CPP is issued in WHO format by the health authority of the country of origin and legalized through the Ministry of Health, the Ministry of Foreign Affairs and the Iraqi Embassy.
• Bringing a CFS remains useful as a communication document, but this article does not cite it as a statutory material.

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 Drug Registration Regulations is graded secondary and must not be cited as a legal provision (hosted at https://pharmexcil.com/uploadfile/ufiles/380351111_drug_regpdf.pdf; the official original was not obtained). The other two are graded primary and verified, and primary, indirectly verified (content obtained through indexed snippets), respectively.

Excerpts of the original provisions:

• Section E item 2 (English original): «CPP issued by the health authority of the country of origin of the manufacturer legalized officially: from Ministry of Health, Ministry of Foreign affairs and Iraqi Embassy in the country of origin of the manufacturer (including the number and date of registration and that the product is freely sold in the country of origin). e.g.: according to WHO form.»
• Reading: the CPP is issued by the health authority of the manufacturer’s country of origin, legalized through the Ministry of Health, the Ministry of Foreign Affairs and the Iraqi Embassy; it must state the registration number and date, that the product is freely sold in the country of origin, and it follows WHO format.
• Section D (for contrast): the only item touching on the product and the country of origin is item 3, «manufacturer registration certificate in the country of origin officially legalized» — pointing to the registration standing of the manufacturer, not the marketing status of the product.

3. Expert insights

Insight 1 | The confusion of CPP with CFS starts with half a sentence in the clause. When listing the contents of the CPP, Section E item 2 adds that the product is freely sold in the country of origin. Lifted out of context, that half sentence reads as if Iraq wants a document proving free sale, and the CFS is then supplied. In fact the CPP is a product certificate in WHO format, issued by the pharmaceutical authority of the country of origin and carrying its own registration number; the CFS has no place in the Iraqi official list.

Insight 2 | Cross-border comparison: in which markets is a CFS a hard requirement. The Medical Device Export Sales Certificate issued in China under Article 74 of the device supervision regulations is driven by importer-country requirements, as are the Certificate to Foreign Government of the US FDA and the Free Sale Certificate issued by EU competent authorities. Saudi Arabia’s SFDA and the UAE’s MOHAP expressly list the CFS among registration materials. Transplanting that experience to Iraq is the second channel through which the misreading spread.

Insight 3 | Debunking: the claim that a CFS is statutorily mandatory in Iraq is not supported by any verifiable official provision. GRZAN searched the six items of Section D, the pharmaceutical requirements of Section E, the general provisions of Section A and the procedures of Section B one by one; the combination free sale does not appear. All sources asserting a mandatory CFS are checklists compiled by service providers. Because the source sites were unreachable this round, the finding is that nothing was retrieved, not that the authorities never require it.

Insight 4 | Not officially required and costly to leave behind can coexist. Iraqi administration relies heavily on counter staff judgement, review criteria are not public (Country Profile 2020, Section 6.7), and a window demanding an extra CFS on the spot is routine. GRZAN separates preparation from characterization: bring the CFS in the dossier, but never claim it is statutory.

Insight 5 | The document the official text expressly requires to be legalized is item 3. In Section D the only item qualified by officially legalized is the manufacturer registration certificate. Legalization resources should be concentrated there: arrange the English translation of China’s Medical Device Production Licence or its annex, then run the chain of notarization, the Ministry of Foreign Affairs and the Iraqi embassy in China, rather than spending the same money twice on a CFS.

4. Practical recommendations

• GRZAN labels every document with a source grade — official checklist, administrative notice, purchaser requirement, or practical convention — and files the CFS under the last two, never under statutory materials.
• Direct the legalization budget first to the country-of-origin manufacturer registration certificate. Practical estimate: the notarization, foreign ministry and embassy chain usually takes weeks to months (no official provision found) and must be scheduled backwards.
• If CFS from several countries are already held, attach them anyway marked as supplementary, to avoid an on-the-spot rejection for a missing document.
• When a window rejects a file for lacking a CFS, politely ask for the written basis or the number of the ministerial instruction; if it is an internal requirement, supply the document, but never acknowledge in correspondence that it is statutory.
• Maintain a country-by-country comparison of attitudes toward the CFS, so the Saudi or UAE dossier is never copied verbatim to Iraq.

5. Verification checklist

• □ Read through the six items of Section D and search the full text for the phrases free sale and free sale certificate.
• □ Check the issuing authority and the three-tier legalization chain of the CPP in Section E item 2, and confirm it sits in the pharmaceutical section.
• □ Retrieve the WHO CPP template (WHO Technical Report Series) and confirm the fields that distinguish it from an ordinary CFS.
• □ Take evidence from companies that completed registration within the last 12 months: whether a CFS was demanded and by whom.
• □ Search the qualification clauses of KIMADIA tender announcements and confirm whether a CFS is separately required at the tender stage.
• □ Re-check within China the availability and issuing authority of the Medical Device Export Sales Certificate as a backup communication document.
• □ Re-verify whether the official documents cited in this article have been replaced by subsequent instructions or resolutions (verification baseline date: 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