Iran Medical Device Regulatory Updates for 2026

1. Key takeaways

The changes in Iranian medical device regulation concentrate along three main lines: regional mutual recognition (Paragraph B of Article 72 of the Seventh Development Plan Law), import tightening (Article 1 of the Law on Maximum Utilisation of Domestic Production plus Paragraph A of Article 72), and digital regulation (the four-way linkage of IRC and identification codes). GRZAN’s assessment: corporate actions over the next 12 months should be scheduled along these three lines, rather than along the registration progress of individual products, because the three lines move on their own statutory and administrative timetables and a product-by-product view hides the changes that affect the whole portfolio at once. This article is a rolling update and is reviewed once every quarter, so that the three lines can be re-read as the underlying facts move.

2. Legal basis

1. Law on the Administration of Medical, Pharmaceutical, Food and Beverage Affairs, FAOLEX LEX-FAOC227692, dated 1955-06-20, Articles 1, 3 and 11. This is the base law on which the product approval, the labelling prohibition and the penalty provisions all rest.
2. Law on the Seventh National Development Plan of the Islamic Republic of Iran, in force for the Iranian calendar years 1403–1407, Chapter 14, Article 72: Paragraph A (self-sufficiency mechanisms by the end of year 1; export bans announced 1 year in advance), Paragraph B (regional mutual recognition by the end of year 2; registration certificates, market access licences and joint production quality certificates), preamble (medical device export target exceeding 1 billion euros). The two paragraphs together define both the opening and the restricting signal for the import environment.
3. Law on Maximum Utilisation of Domestic Production and Service Capacity and Support of Iranian Goods, Iranian calendar year 1398 (2019), 24 articles in total, Article 1 (51% localisation; registration of imports refused for like goods). This is the second gate that operates after product registration, at the stage of import registration.
4. Value Added Tax Law, approved 2021-05-23, in force 2022-01-03, standard rate 9% (6% + 3%); the annual budget law may raise it, with a practical estimate of around 10%. The rate must be re-verified each fiscal year from the budget law.
5. Direct Taxes Law, 1987, Article 105, corporate income tax 25%. This anchors the income tax planning of any local entity or branch.
6. Executive Regulation of the Supreme Health and Food Safety Council, FAOLEX LEX-FAOC227712, adopted 2019-01-14, amended 2020-10-07, issued under Article 7 of the Permanent Provisions Law on National Development Plans (2017-02-15). This is the instrument through which the council’s health and food safety competencies are put into execution.
7. Iranian Transactions and Sanctions Regulations of the United States, 31 C.F.R. Part 560, § 560.530; the OFAC list of medical devices requiring specific authorisation is updated periodically. Companies must check the current version of the list rather than relying on any saved copy.
8. Export Control Law of the People’s Republic of China, adopted 2020-10-17, in force 2020-12-01, Articles 2 and 12. This governs the export side for companies shipping from China and is the eighth anchor of the consolidated view.

3. Expert insights

Insight one: the three lines do not point in the same direction and must be managed separately. Regional mutual recognition is an opening signal, import tightening is a restricting signal, and digital regulation is a neutral but mandatory compliance signal. A company that sees only one of the three will judge the environment wrongly, because each line moves on its own timetable and pulls the overall picture in its own direction, and a strategy built on a single line will be contradicted by the other two.

Insight two: digital regulation is the most certain near-term change. The linkage between the IRC and identification codes is already in actual operation and is directly connected to foreign exchange and customs clearance. This item does not depend on any legislative process, and it is the action that most urgently needs to be implemented now, ahead of anything that still awaits a legal milestone, because it affects shipments that are already on their way.

Insight three: the fiscal year milestone is the natural rhythm for scheduling. The Iranian fiscal year begins on 21 March, and VAT rate verification, annual reviews and budget adjustments should all be anchored to that milestone rather than to the calendar year, so that corporate cycles match the cycle in which the regulatory variables actually change and the company is not reviewing a rate that has already moved twice.

4. Practical recommendations

5. Verification checklist

• □ The full self-check of IRC and identification code status has been completed
• □ The re-verification of the comparison with domestic like products has been completed and import blocking risks identified
• □ The regional spillover market map has been drawn (regional countries, civilisational sphere, Eurasian Economic Union)
• □ The applied VAT rate for the current fiscal year (from 21 March) has been verified
• □ The annual re-verification of the ISIRI mandatory standards list has been completed
• □ The registration validity period ledger has been updated and renewals scheduled
• □ The current version of the OFAC list of medical devices requiring specific authorisation has been reviewed
• □ A quarterly rolling review mechanism has been set up for this article

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Iranian market. Our team manages adverse event reporting and recall coordination with IFDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com