Iraq’s Vigilance Scope Excludes Medical Devices

1. Key takeaways

The principal role of the Iraqi Pharmacovigilance Centre is to monitor adverse reactions to medicines, vaccines, herbal products and biopharmaceutical products — medical devices are not on the list. The 2024 edition of the Iraqi Pharmacovigilance Guidelines for Healthcare Professionals anchors all of its terminology to medicinal product and medicine throughout, without defining or even mentioning devices; the 2021 WHO review states in the same document that the authority to recall, suspend and withdraw medicines is exercised by the centre in collaboration with the Inspection Directorate, which may confiscate and destroy substandard and falsified medicines. The official literature itself states that neither the Ministry of Health nor the private sector has an electronic tracking system, and that the only way to identify problem medicines is on-site inspection together with reports from companies and healthcare professionals. GRZAN’s conclusion is that, across the four official documents obtained in full, the indications of scope are highly consistent and mutually corroborating, so it can be written that, as of the verification date of 2026-10-29, no statutory adverse event reporting deadline, FSCA reporting obligation or recall system for medical devices was found in any legally reachable official channel or officially hosted repository. Because the Ministry of Health website, the Ministry of Justice website and the official legal databases were unreachable during this check, this conclusion must not be restated as a claim that Iraq has no device vigilance obligations.

• The centre’s monitoring scope names four product classes; devices appear nowhere.
• Recall, suspension and withdrawal authority for medicines is exercised with the Inspection Directorate, which may also confiscate and destroy.
• There is no electronic tracking system on either the ministry or the private-sector side.
• No device adverse event reporting deadline, FSCA duty or recall system was found as of 2026-10-29.

2. Legal basis

Source level: the WHO article is a primary source, verified; the 2024 guidelines are a primary source, indirectly verified — the URL is an official Ministry of Health storage-domain path, but the domain is blocked by Cloudflare, and the text was obtained through a search cache without a direct download check.

Excerpts from the sources:

• Scope (decisive wording): the main role of the Pharmacovigilance Centre is to monitor adverse reactions to medicines, vaccines, herbal products and biopharmaceutical products in both the private and public sectors.
• Recall authority: the Pharmacovigilance Centre, in collaboration with the Inspection Directorate, has the authority to recall, suspend and withdraw medicines; disciplinary actions include confiscation and disposal of substandard and falsified medications.
• Traceability gap: neither the Ministry of Health nor the private sector has an electronic tracking system; therefore the only way to identify these medications is through the health ministry inspections and the reports from pharmaceutical company representatives or health care providers.

3. Expert insights

Insight 1 | The method of proof for the decisive conclusion is four-way corroboration, not concluding because nothing was found. First, the duty list in the WHO review names four classes only. Second, the glossary of the 2024 guidelines anchors ADR, adverse event, biologic and SmPC entries to medicinal product and leaves devices undefined. Third, an exhaustive search of the Public Health Law finds the word for recall 2 times, both in the licence-revocation sense, with no product-recall sense. Fourth, the addressees of the 2026 MAH guideline and the 2026 e-notification are uniformly pharmaceutical companies and marketing authorisation holders. Four evidence streams point the same way; subject to the unreachability of the source sites above, the conclusion can only be written as not found plus highly likely not covered, without a final assertion.

Insight 2 | Horizontal comparison: three mature markets have express provisions; nothing corresponding was found for Iraq. In the United States, 21 CFR 803 requires deaths and serious injuries involving devices to be reported within 30 days of awareness and events requiring remedial action within 5 working days; the EU MDR requires serious incidents to be reported within 15 days, serious public health threats within 2 days and deaths or serious deterioration of health within 10 days; China pairs the Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices with the national device adverse event monitoring information system and imposes clear case-report duties on licence holders. At these positions for Iraq, nothing corresponding was found; because the Ministry of Health website and the official legal databases were unreachable, this gap must not be further read as certainly absent.

Insight 3 | The real exposure of device companies is not failure to report but being inspected. Post-market control in Iraq is triggered mainly by on-site testing and inspection and is not premised on vigilance reports: the nonconforming-goods disposal of Article 26, the confiscation of Article 96 and the criminal liability of Article 99 can all be set in motion by an inspection, without any prior failure by the company to report. For companies, this means the anxiety invested in whether reports are filed on time is misdirected; what deserves the investment is on-site verifiability — whether batch numbers, expiry dates, storage conditions, labels and registration files are mutually consistent on site.

Insight 4 | Falsification check: the circulating claim that Iraq requires medical device companies to submit adverse event reports has no official source as of the verification date. The claim appears on the pages of several consultancies, commonly phrased as post-market adverse event reporting is required or handling must follow the FSCA process; item-by-item verification found no support in any Iraqi official text. Its origin most likely has two strands: transplanting the device vigilance requirements of the Gulf neighbour SFDA onto Iraq, or over-extending the addressees of the MAH Good Pharmacovigilance Practice Guideline — pharmaceutical companies and marketing authorisation holders — to all health-product companies. When citing, state that its true scope is medicines.

Insight 5 | In vitro diagnostic (IVD) reagents occupy a marginal position. In the phrasing of some partners, IVD reagents are placed in the medical preparations context and thereby drift toward the reach of Article 26. GRZAN does not presume: practical estimate — follow the category into which the product was placed at the registration stage (no official provision found).

4. Practical recommendations

• Do not write a line about submitting device adverse event reports to the IPvC into the compliance checklist of an Iraqi project; professional readers will spot it at once.
• Build an internal device event ledger with fields following the four elements of the medicines side (identifiable patient, identifiable reporter, suspected product, suspected adverse event), with the review interval set by the company. Practical estimate: the interval is set by the company itself (no official provision found).
• Route customer complaints and on-site anomalies through the existing Scientific Bureau channel and keep records, to demonstrate that the company has exercised due care.

5. Verification checklist

• □ Reopen the WHO EMHJ article PDF and re-check the four product classes in the duty list and whether the term medical devices appears.
• □ Once the full text of the 2024 guidelines for healthcare professionals is obtained, search its glossary entry by entry for any definition of medical devices.
• □ Search storage.moh.gov.iq for any Ministry of Health document whose title contains the Arabic term for medical devices.
• □ Check the addressee wording of the 2026 e-notification and confirm it remains pharmaceutical companies and Scientific Bureaus.
• □ Re-check whether the official documents cited in this article have been replaced by later directives or resolutions (verification baseline of this article: 29 October 2026).

Regulatory information verified to 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 manages adverse event reporting and recall coordination, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com