Article 28 Periodic Inspection of Premises and Operating Theatres

1. Key takeaways

Article 28 of Public Health Law No. 89 of 1981 empowers the public health laboratories to carry out two kinds of periodic examination. First, periodic sampling of everything displayed to citizens in the way of food, drink, and medical and pharmaceutical preparations, to determine whether it is fit for consumption or human use without harm to public health. Second, examination of operating theatres and of the staff, apparatus, materials and furniture within them. The word for apparatus in the second limb belongs to the sense of operating-theatre fixtures and equipment; it is wording of in-facility hygiene supervision, not a basis for periodic sampling of medical devices as regulated products. GRZAN’s judgement is that, as of the verification date of 2026-10-29, no periodic sampling regime for medical device products was found in any legally reachable official channel — no product plan, no judgement criteria and no retest procedure. Because the Ministry of Health website and the official legal databases were unreachable during this check, this statement must not be restated as a claim that Iraq has no device sampling regime.

• The first limb covers market sampling of goods displayed to citizens: food, drink, medical and pharmaceutical preparations.
• The second limb covers operating theatres and their staff, apparatus, materials and furniture — a premises, not a product.
• No periodic sampling regime addressed to medical device products was found as of 2026-10-29.

2. Legal basis

Source level: primary source, verified. — https://faolex.fao.org/docs/pdf/irq149622.pdf

Excerpts of the provision:

• Article 28 assigns to the public health laboratories the conduct of periodic examinations of — first — everything displayed to citizens by way of food, drink and medical and pharmaceutical preparations, to determine its fitness for consumption or human use without harm to public health; and — second — operating theatres and the workers in them, the apparatus, the materials and the furniture.

3. Expert insights

Insight 1 | The first limb is market sampling and the second is facility hygiene supervision; their objects sit at different levels. The operative words of the first limb are displayed to citizens, pointing to goods that have entered circulation and can be publicly purchased. The operative words of the second limb are operating theatres, and these, together with the staff, apparatus, materials and furniture, constitute a premises, not a product. GRZAN therefore holds that treating the second limb as the basis for periodic sampling of medical devices in use in Iraq confuses the two usages of the word apparatus.

Insight 2 | Horizontal comparison: product surveillance and facility hygiene surveillance are two systems in most jurisdictions, but Iraq wrote them into one article. On the China side, product surveillance consists of national-level surveillance sampling and the post-market monitoring duties of the licence holder, while infection control is managed separately by the health administration and the disease-control system; in the European Union, market surveillance by the competent authorities and the quality-control systems of healthcare institutions each carry their own part. Article 28 places the examination of displayed goods and the examination of operating theatres, their apparatus and furniture under one and the same laboratory duty. This drafting is not a legislative oversight; it follows from the fact that the purpose of Law No. 89 is public health itself, not the governance of product quality.

Insight 3 | Falsification check: the circulating claim that Article 28 of Iraqi law provides post-market periodic sampling of medical devices does not hold. There are three errors. First, in the second limb the Arabic word for apparatus stands parallel with materials and furniture, and its semantics point to the furnishings and fittings of the operating room. Second, the objects of the first limb are still medical and pharmaceutical preparations, that is, drug preparations, not devices. Third, in the exhaustive keyword search of the whole law, the word for recall or revocation appears only 2 times, both in the sense of revoking a licence, and the word for standard appears 0 times — there is no standards clause, and no basis for device sampling judged by standards was found (the same qualifications as above apply).

Insight 4 | What really affects device companies is not being sampled but requirements passed down from the customer side. The second limb makes operating theatres periodically inspected premises, which means the condition of equipment in hospital use can become an inspection item. The pressure suppliers feel usually comes from customers: tenderers or hospital procurement departments may rely on this to demand installation and commissioning records, cleaning and disinfection validation, and periodic calibration certificates. Once such requirements are written into tender documents they become binding — a matter separate from whether the product needs registration.

Insight 5 | Enforcement intensity cannot be inferred from this article. Article 28 fixes no sampling frequency, sample size or post-nonconformity disposal procedure, and no supporting periodic sampling plan document has been seen publicly. One set of reference figures comes from the public statements of Sabah Nouri al-Khazali, head of the Inspection Department: 21,675 inspection visits in 2024 and destruction orders covering 8,962,207 nonconforming medicines (an official’s remarks as relayed by media; no official original found).

4. Practical recommendations

• When GRZAN prepares the compliance scope table for an Iraqi project, it labels Article 28 as a facility-level supervision basis, not a product-sampling basis, so that team members and clients do not mis-cite it.
• Bid documentation for hospital clients should proactively include installation and commissioning records, cleaning and disinfection validation plans, and calibration certificate templates, drafted by the company according to the product risk class. Practical estimate: state the calibration interval in the instructions for use (no official provision found).
• If a tender document cites Article 28 as the basis for product sampling, GRZAN requires the other party to specify the batch-sampling method and the judgement criteria; the other side usually cannot produce them, on which basis acceptance against the registered technical parameters can be argued.
• For projects involving operating-theatre equipment such as dialysis machines, anaesthesia machines and electrosurgical units, GRZAN recommends building an equipment status ledger through the partner Scientific Bureau, so that unannounced inspections can be handled.
• Where public hospital clients expressly invoke the second limb to demand equipment compliance documents, list the document set and its update frequency in a contract annex to avoid last-minute additions at acceptance.

5. Verification checklist

• □ Check the wording of both limbs of Article 28 in the gazette full text and confirm that the apparatus, materials and furniture phrase sits within the premises context of the second limb.
• □ Search the full law for the words for recall, standard and accessories and re-confirm the counts of 2 and 0 occurrences and the judgement that no product-sampling regime exists.
• □ Verify whether amendment laws Nos. 53 / 71 / 54 / 20 touch Article 28.
• □ Check recent tender documents or client acceptance sheets for clauses citing Article 28 as a product-sampling basis, and record each instance.
• □ Ask a partner hospital for the content list of its most recent operating-theatre inspection and check whether the items actually inspected fall within the reach of the second limb.
• □ 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