The Product Spread Data Sheet (Catalogue)

1. Key takeaways

The fourth document in company-level device registration in Iraq is the spread data sheet of the company products (catalogue). In a country with no product registration system, the catalogue in fact performs the function of a product list filing — the authority can only learn “what this company sells” by reading it, and its quality directly determines whether shipment-by-shipment import licensing runs smoothly. GRZAN recommends at least 9 fields; practical estimate: the field list is a GRZAN recommendation; as of this verification pass, no official template was retrieved in the directly accessible channels, and because the Ministry of Health site was unreachable, the situation must not be stated as “Iraq has no official template”.

• Section D item 4 lists the spread data sheet of the company products (catalogue) as a registration document.
• Because products are not registered, the catalogue is the only carrier of product information available to the authority.
• Recommended nine fields: product name, model, HS code, country of origin, manufacturer, applicable standards, sterilisation status, shelf life and country-of-origin registration certificate number (practical estimate, no official template found).
• Language: application forms accept Arabic and English; scientific data must be in English (Section B items 5 and 6).
• HS codes flow through to customs: Chapter 90 at 15%, Chapter 30 at 10%, Chapter 94 at 15%, Chapter 34 at 10%, HS 84/85 at 30%; a wrong chapter changes both duty rate and competent channel.

2. Legal basis

The requirement sits in the Drug Registration Regulations, issued by the Republic of Iraq, Ministry of Health, Technical Affairs Directorate, Registration Department, bearing no number and no publication date in the copy reviewed. Three provisions are engaged: Section D item 4 lists the catalogue; the closing sentence of Section D states products are not themselves registered; Section B items 5 and 6 govern the accepted languages.

Evidence level: [second-hand source; must not be cited as law]. The original was not obtained; the surviving text is the Pharmexcil reposted PDF (https://pharmexcil.com/uploadfile/ufiles/380351111_drug_regpdf.pdf ). The field list itself is a [practical estimate] with no official template to verify against.

Verbatim extracts of the provisions:

• Section D item 4: «Spread data sheet of the company products (catalogue)».
• Closing sentence of Section D: «Medical Appliances, Disposables products and Laboratory diagnostic kit, themselves are not require to be register».
• Section B items 5 and 6: «Arabic and English are the accepted languages for the application forms.» and «Scientific data should be in English.»

3. Expert insights

Insight 1: why the catalogue carries so much weight here. With products unregistered, there is administratively no second document telling the authority what the company deals in. In countries with product registration, product data lives in the certificate and registration unit and the catalogue is auxiliary; in Iraq it is the sole carrier. GRZAN treats it as a “pre-filing list”, not a marketing brochure.

Insight 2: the HS code is the most expensive column. The codes travel to import: under Customs Tariff Law No. 22 of 2010 and the duty-reduction tables of Council of Ministers Resolution No. 393, HS Chapter 90 carries 15%, Chapter 30 10%, Chapter 94 15%, Chapter 34 10%, HS 84/85 30%. Misclassifying the chapter changes the rate and the competent channel. Article 30 develops the point in full.

Insight 3: sterilisation status and shelf life are columns the official text never mentions but practice keeps asking about. No official provision requires them, yet import licensing and customs use them to judge the nature and handling of the product. GRZAN makes them fixed columns — writing more upfront beats hunting for data at supplementary-document time. Practical estimate: the field list is a GRZAN recommendation (no official provision found).

Insight 4: horizontal comparison — the EU and China have structured product lists; Iraq does not. EUDAMED and the Chinese registration-unit and model tables prescribe fields and granularity; Iraq has no template, so freedom comes with the drafter bearing the burden of explanation. GRZAN sets catalogue rows at Chinese registration-unit granularity — one row per model, not per series.

Insight 5: falsification check — glossy brochures are an expensive misunderstanding. Colour brochures typically carry no HS codes, no sterilisation status and no country-of-origin registration certificate number, and cannot support any downstream stage. GRZAN has seen companies submit printed brochures only to have every item returned at the import licensing stage — the effort saved at registration is repaid with interest at clearance.

4. Practical recommendations

• Structure the catalogue by model, one row per model, filling all 9 fields: product name, model, HS code, country of origin, manufacturer, applicable standards, sterilisation status, shelf life, country-of-origin registration certificate number. Practical estimate: the field list is a GRZAN recommendation (no official template found).
• Follow Section B item 5 on language: produce an Arabic-plus-English bilingual catalogue with scientific data in English; never build a Chinese-only catalogue and translate in haste.
• Complete the HS classification review before finalising, and keep codes consistent with invoice, packing list and import declaration — inconsistency across the three is the most common clearance stoppage in Iraq.
• Mark the catalogue with a version number and compilation date; issue a new version for every model addition and archive it. A changing product list without version records is a common re-registration stumbling block.
• The manufacturing scope must reconcile with the manufacturer registration certificate and system certificate; a category in the catalogue not covered by the system certificate points out a nonconformity to the reviewer on your own initiative.

5. Verification checklist

• □ Request the official catalogue template from the Registration Department, if one exists; the field list here is a recommendation with no official template to verify against
• □ Confirm whether Section D item 4 still reads “Spread data sheet of the company products (catalogue)”
• □ Search official sites using «البيانات التفصيلية لمنتجات الشركة» for the current name and format requirements
• □ Re-check the HS codes row by row against the chapter-level duty rates described in article 30
• □ Verify that catalogue product names and the scopes of the manufacturer registration certificate and system certificate cover one another
• □ Establish a catalogue version ledger recording version number and submission date of every model addition
• □ Re-verify whether the cited official documents have been superseded (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 prepares registration dossiers and legalisation chains, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com