Iraq Has No Dedicated Medical Device Law

1. Key takeaways

As of 29 October 2026, in every lawfully accessible official channel and officially hosted legal database, no dedicated medical device law for Iraq was found. The current federal parent statute, Public Health Law No. 89 of 1981 (as amended), contains 106 articles. Its word for devices appears 17 times, but always on senses such as agencies, hearing aids, or operating-room equipment; never a medical device in the regulatory sense. Advertising appears 0 times, adulteration or counterfeiting 0 times, standard or specification 0 times; withdrawal appears 2 times, both on revoking a licence. Iraq constrains devices not through product registration but through business registration plus shipment-by-shipment import licensing. GRZAN concludes that applying EU MDR classification logic to Iraq is wrong from the first step.

• No dedicated medical device law was found in any lawfully accessible official source as of the verification date.
• Public Health Law No. 89 of 1981 has 106 articles and no device definition, classification, or approval regime.
• Iraq’s binding practice rests on business registration and shipment-by-shipment import licences, not product registration.
• Because the MOH website, the Ministry of Justice site, and the official legal database were unreachable, the finding is stated as not found, not as non-existent.

2. Legal basis

The statutory record that can be verified is the amendment history of Public Health Law No. 89 of 1981, summarised below.

Source grade: primary, verified. Checked against the official gazette text reproduced by FAOLEX (irq149622.pdf, marked as in force); the index entry appears in ECOLEX under the Public Health Law No. 89 of 1981 record.

Evidence boundary. The Iraqi official domains reachable during this verification were kimadia.gov.iq, mop.gov.iq, cosqc.gov.iq, and cabinet.iq. The MOH site and its legacy mirror were blocked sitewide by Cloudflare (curl 403, real browsers blocked identically); the Ministry of Justice site failed to connect; parliament.iq failed the reachability check; iraqld.hjc.iq returned 403. The law text cited here comes from the gazette text held in FAOLEX, marked as in force. The negative conclusions should be rechecked once the MOH site and the official legal database become reachable again.

Excerpts from the articles:

• Article 3, item 11: provides for the supply of drugs, sera, vaccines, injection solutions, and various medical supplies. A duty-empowerment clause, creating no registration or approval regime.
• Article 105: regulations, instructions, and announcements may be issued to facilitate implementation of the law. The legal source of authority for every MOH ministerial document.
• Article 106: the law entered into force 60 days after gazette publication.

3. Expert insights

Insight 1: a duty clause for medical supplies exists, but no definition clause. Article 3, item 11 places the supply of various medical supplies among the duties of the Ministry of Health, yet defines nothing and attaches no risk classification, technical review, or marketing authorisation procedure. GRZAN reads this as a supply-security clause, not a market-access clause: the legislator’s concern was that the ministry must get such goods into Iraq, not what is reviewed before they reach the market.

Insight 2: the comparison with China shows the nature of the gap. China’s medical device regulation (State Council Decree No. 739, revised 2021) defines medical devices in Article 6 and applies Class I/II/III management under Article 4; the EU MDR (EU) 2017/745 sets 22 classification rules in Annex VIII. At the corresponding position Iraq is blank. This is not loose drafting; it is a legislative choice that never made devices an independent object of regulation, and the two situations demand entirely different strategies.

Insight 3: refutation of the two most widespread claims. First, that Iraq has a Law No. 37 of 2010 on the Registration and Importation of Pharmaceuticals and Medical Devices: no such law was found in ECOLEX, FAOLEX, the Ministry of Justice legal database, or the official gazette. It is highly suspected to be fabricated or badly misquoted, but no definitive assertion is made before the MOH website and the official legal database become reachable, and it must not be used as a legal basis. Second, that the 2021 amendment brought device regulatory reform: the text of Law No. 20 of 2021 has been obtained and contains only 2 articles, granting a cash food allowance to senior resident doctors, with nothing on devices, drugs, vigilance, recall, or labelling (expanded in Article 08).

Insight 4: absence at the level of statute does not mean no procedures. GRZAN must remind clients that in practice Iraq retains two gates, business registration and shipment-by-shipment import licensing; their basis lies in ministerial instructions and administrative notices, not statute. Every requirement a company meets in Iraq should be traced back to a specific MOH instruction or KIMADIA notice, not to a provision of law. Reading no statutory text as no compliance duty is the most common point of failure in Iraqi projects.

Insight 5: exhaustive keyword search is itself a reusable verification tool. Both occurrences of withdrawal concern licence revocation, and standard or specification appears zero times, showing Iraq has no statutory mechanism for referencing standards. Anyone claiming Iraq requires devices to meet a named standard must find its origin in a ministerial document or tender announcement, never in the law. GRZAN applies this negative-search method to every jurisdiction before drafting anything on regulatory scope.

4. Practical recommendations

• When GRZAN takes over an Iraqi project, the first step is not classification rules but mapping the client’s HS codes and product purpose onto the chapters of Tariff Law No. 22 of 2010, and judge which authority’s scope the product falls under. Practical estimate: this step usually takes 1–2 weeks (no official provision found).
• Do not proactively submit a product registration application form. The Registration Department accepts business registration; at product level the route is shipment-by-shipment import licensing. Filing at the wrong level is the most common cause of delay.
• Where a tender document, contract, or agency agreement cites an Iraqi medical device law, GRZAN requires the client to demand the Arabic title and gazette issue number; if it cannot be produced, treat it as non-existent.
• Build an internal regulatory scope table: mark every obligation as one of four classes, statute, ministerial instruction, administrative notice, or market practice. Mixing the four is the largest single risk source in Iraqi compliance plans.
• In parallel, assess the separate regime of the Kurdistan Region. This article describes the federal (Baghdad) position; the Region has an independent health administration, expanded in Article 10.

5. Verification checklist

• □ Search ECOLEX for Public Health Law No. 89 of 1981 (LEX-FAOC149622) and confirm the current text is still marked in force.
• □ Re-run the Arabic keyword search across the full text for the device, supplies, withdrawal, advertising, and specification terms, confirming the hit counts and sense readings reported here.
• □ Check each amendment law (No. 53/1986, No. 71/1988, No. 54/2001, No. 20/2021) and confirm no other amendment touches devices.
• □ Search ECOLEX and FAOLEX for Law No. 37 of 2010 and confirm a zero result.
• □ Obtain the full text of Law No. 20 of 2021 and confirm it covers the resident doctors’ food allowance.
• □ Where tender documents cite an Iraqi medical device law, require the Arabic title and gazette issue number and compare item by item.
• □ Recheck whether the documents cited here have been superseded (verification 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 manages KMOC (Kurdistan) and federal MOH registration procedures, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com