The 1955 Medical, Pharmaceutical and Food and Beverage Affairs Law of Iran

1. Key takeaways

Iran has no statute named a “medical device law”. Authority over devices flows from the 1955 Law Concerning the Regulations on Medical, Pharmaceutical and Food and Beverage Affairs. That law remains in force today, and two of its provisions define the entire regulatory posture that companies still face. Article 3 establishes the “prior approval” principle, which is the original legal basis on which Iran subjects imported devices to market-access control; Article 11 sets out penalties, in the form of fines and imprisonment, which supply the power for market surveillance and enforcement. A company that understands this arrangement will also understand why Iranian enforcement logic leans toward “administrative licensing” rather than “after-the-fact accountability”: the gate is placed at the point of entry, and the sanction attaches to entering or selling without passing through it. For planning purposes, this means that compliance effort in Iran should be weighted heavily toward securing approvals before any commercial movement of goods, because errors discovered after shipment are not merely procedural defects but potential offences under the foundational statute. It also explains the particular attention Iranian reviewers pay to labelling and composition, both of which fall squarely within the scope of the same article. In day-to-day terms, the practical effect is that approval is treated as something a product must already possess when it reaches the border, and every commercial plan for Iran should be built around that premise rather than around the hope of remedying a missing approval after the fact.

2. Legal basis

1. The Law Concerning the Regulations on Medical, Pharmaceutical and Food and Beverage Affairs (FAOLEX number LEX-FAOC227692), published on 20 June 1955: Article 3 (import, manufacture and sale require the prior approval of the Ministry of Health, and unauthorised alteration of composition or labelling is prohibited) and Article 11 (penalties of fines and imprisonment for violations).
2. The Executive Regulation of the Supreme Health and Food Security Council (FAOLEX number LEX-FAOC227712), adopted on 14 January 2019 and amended on 7 October 2020, issued under Article 7 of the Law on Permanent Provisions of National Development Plans (15 February 2017). This instrument moves policy-making authority for health and food security into a cross-sectoral supreme council and is the most recent structural layer above the foundational statute.

3. Expert insights

Insight one: the prior-approval principle sets the tone that absence of authorisation means unlawfulness. Article 3 positions approval as a precondition to import and sale, not as a registration to be filed afterwards. This explains two typical risk patterns seen in the Iranian market. First, goods that have already arrived at port without an IRC cannot clear customs, because no approval exists for them to rely on. Second, labels that have been altered without authority are treated as unlawful even where the product itself is fully compliant, because Article 3 expressly prohibits changing the label. Both patterns arise from the same design choice, and both are avoidable if the approval chain is completed before goods move. The pattern also explains why Iranian reviewers ask for the approval trail in a fixed order, since each document in that trail presupposes the ones before it.

Insight two: the 2019 executive regulation added the policy layer. The Executive Regulation of the Supreme Health and Food Security Council was issued under Article 7 of the 2017 Law on Permanent Provisions of National Development Plans, and it assigns the making of health and food security policy to a cross-sectoral supreme council. For companies, this means that device policy in Iran is no longer decided by a single department; it is pulled by the combined objectives of “health plus food security plus industrial development”. This is also why import control and domestic-production policy tend to overlay one another in practice, and why an application that is technically sound can still be shaped by policy considerations outside the device dossier itself. Reading policy signals alongside technical requirements is therefore part of the Iranian work, not an optional extra.

Insight three: the composite structure of an old law plus new directives makes article citation difficult. GRZAN has found in practice that the accepting opinions of the Iranian authorities frequently cite ministerial directives rather than provisions of the foundational law. When preparing appeal or communication materials, companies should prepare both the foundational provisions and the ministerial directive cited in the current case, and submit the two sets of bases in parallel. Presenting only the statute invites the response that the operative instrument is the directive; presenting only the directive leaves the appeal without its deepest legal root.

4. Practical recommendations

1. Make Article 3 the first item of internal training: every colleague involved in Iran business should understand that importing or selling without approval is a criminal risk under the foundational law, not a minor administrative defect to be corrected later.
2. Route any label change through the formal change channel: no adjustment to the wording of labels, instructions for use or packaging may be executed by a marketing department on its own initiative, because unauthorised alteration of the label is expressly prohibited.
3. Build a two-layer basis library: one repository holds the foundational provisions (the 1955 law and its FAOLEX-recorded text), the other holds the ministerial directives cited in current acceptances, and the two are cross-indexed so that any citation can be assembled quickly.
4. Follow the policy output of the supreme council: cross-sectoral policies touching food security and health feed directly into device import priorities, and tracking them gives early warning of shifts that a purely technical reading of the rules would miss.

5. Verification checklist

• □ The FAOLEX-recorded text of the 1955 law (number LEX-FAOC227692) has been retained on file together with a summary
• □ It has been confirmed whether the product categories to be imported fall within the “prior approval” scope of Article 3
• □ Internal change approval was completed before labels and instructions for use were finalised, and no unauthorised edits were made
• □ A cross-index table linking the foundational provisions library and the ministerial directives library has been established
• □ The impact of recent policies of the Supreme Health and Food Security Council on the categories to be submitted has been assessed

Regulatory information verified as of October 29, 2026.

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 IFDA (Iran FDA) registration procedures, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com