The Company Registration Form (Appendix 4)

1. Key takeaways

The first document in the company-level registration of a medical appliances business in Iraq is the company registration form (Appendix 4). The official text requires it in one copy, signed and stamped by the person responsible on the establishment. The form registers the company and has no product-by-product fields; devices, disposables and laboratory diagnostic kits are themselves not required to be registered. Whoever signs and stamps the form is the responsible party in all later dealings with the Registration Department, the Inspection Department and the State Company for Marketing Medicines and Medical Appliances (KIMADIA). GRZAN notes the requirement comes from a reprint with no instrument number and no publication date, citable as fact only, not as law.

• One copy only: the system takes no product-by-product or plant-by-product filings; the applicant is a single legal entity.
• Product information is carried by the catalogue under Section D item 4, not by the form.
• The signatory is the responsible party: inspection notices, supplementary-document demands and administrative penalties all follow that signature.
• Market access operates through company registration plus shipment-by-shipment import licensing, not product registration.
• The source is a second-hand reprint without number or date and cannot be cited as Iraqi law.

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. The instrument bears no number and no publication date in the copy reviewed. The operative provisions are Section D item 1 on the form, Section B item 1 on the receiving authority, and the closing sentence of Section D on product scope.

Evidence level: [second-hand source; must not be cited as law]. The .gov.iq original could not be obtained on this pass (moh.gov.iq is blocked site-wide by Cloudflare); the surviving text is a PDF reposted by Pharmexcil: https://pharmexcil.com/uploadfile/ufiles/380351111_drug_regpdf.pdf . Citations must read “according to a document published by the Registration Department of the Technical Affairs Directorate of the Iraqi Ministry of Health”, never “article X of Iraqi law”.

Verbatim extracts of the provisions:

• Section D item 1: «Company registration form to be filled in one copy Signed and stamped by the person responsible on the establishment. (appendix 4)» — one copy, signed and stamped by the person responsible on the establishment (Appendix 4).
• Section B item 1: «The responsible authority for registration is MOH/ technical affairs directorate/ registration department.»
• Closing sentence of Section D: «Medical Appliances, Disposables products and Laboratory diagnostic kit, themselves are not require to be register».

3. Expert insights

Insight 1: “one copy” is a constraint on how the filing is made, not a typographic detail. The text fixes the submission at one copy, so the Registration Department sees the applicant as a single legal entity, with product data carried by the catalogue of Section D item 4. Splitting the form by product line or plant creates a version that mismatches the receiving convention and is returned for rework in the first round.

Insight 2: the signatory equals the responsible party — the three most expensive words in the provision. “The person responsible on the establishment” means the head of the establishment, not a sales representative, a service provider’s authorised signatory or a registration agent. Once signature and seal sit on the form, inspection notices, supplementary-document demands and the administrative penalties of article 96 of Public Health Law No. 89 of 1981 all trace back to that signature. In GRZAN’s Iraq projects the most frequent risk is letting a local agent sign: years later, when the agent is replaced, the responsible party cannot be migrated and ownership of the registration hangs.

Insight 3: falsification check — no basis for a device product registration application form was retrieved in any directly accessible channel. As of this verification pass (29 October 2026), no such form was retrieved in any official channel or officially hosted repository; since the Ministry of Health site (moh.gov.iq), the Ministry of Justice site (moj.gov.iq) and the official legal repositories were unreachable, this must not be stated as “Iraq has no product registration application form”. On the document obtained, the receiving tier is company registration and the product tier is shipment-by-shipment import licensing (إجازة الاستيراد); voluntarily attaching a self-drafted product registration form is the typical tier mismatch.

Insight 4: horizontal comparison — China has a registrant system; Iraq has no such layer. China’s device regulations (State Council Decree No. 739, 2021 revision) let an overseas registrant designate a Chinese entity to perform obligations; EU MDR (EU) 2017/745 requires an EU authorised representative. Iraq has neither concept in statute, so responsibility falls on the head of the establishment who signs. That is why GRZAN uses a self-operated-entity holder model: its local entity holds the certificate while final ownership and control stay with the manufacturer.

4. Practical recommendations

• The signatory must be the head of the establishment in person, with the seal affixed. GRZAN requires the signatory’s identity documents and authorisation chain before submission; no agent signs in the company’s place.
• Prepare one original only; attachments go in the same batch under Section D items 2–4, never split by filing.
• Fix the holder arrangement at launch: a third-party signature makes the responsible party hard to migrate later; a self-operated entity keeps control with the manufacturer. Write this into the agency agreement.
• Practical estimate: the official text gives a review time of 14 days and evaluation not exceeding 90 days (same second-hand document, Section B items 2 and 4); actual timelines depend on offline follow-up, and the circulated 8–24 months has no official source (no official provision found).
• Before submission, request the latest Appendix 4 form and its version number (Bander No.) and confirm this version has not been superseded.

5. Verification checklist

• □ Request the Appendix 4 form original and version number from the Registration Department and compare whether it is current
• □ Re-check whether the signatory field still requires the head of the establishment to sign and stamp, and whether witness or notarisation requirements were added
• □ Verify whether “one copy” in Section D item 1 has been changed by a later instruction to multiple copies or electronic submission
• □ Search .gov.iq for the Drug Registration Regulations original and confirm its number and date; until obtained, do not label it a statutory provision
• □ Search Ministry of Health and Technical Affairs Directorate sites in Arabic using «استمارة تسجيل الشركة» and compare the Arabic form fields
• □ Check agency agreement provisions on the signing party and certificate ownership; confirm the manufacturer retains final control
• □ 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