🇮🇷 Iran medical device regulatory data

An advertising licence in respect of the claims put forward in an advertisement for any material or product within the Directive's scope — which includes medical equipment — is issued only in accordance with the confirmation (تأییدیه) of the Ministry of Health, Treatment and Medical Education or of the other relevant authorities.

An advertising licence is issued only for permitted materials, products and services, and only where the persons, companies and institutions concerned have previously obtained from the Ministry of Health, Treatment and Medical Education, the Medical Council Organization or other competent health-sector authorities the establishment, operation or manufacturing licence, or the product import and distribution licence, or the medical/paramedical services licence covering the subject of the advertising. The authority for enquiries on materials and products is the Food and Drug Organization.

Advertising of medical equipment (تجهیزات پزشکی), together with the other health products and medical matters listed in Art. 1, requires an advertising licence from the Medical Council Organization (سازمان نظام پزشکی) when carried out through any of the media listed in Art. 3. Those media expressly include advertisements appearing on product packaging and labels, environmental advertising of any kind, printed matter such as leaflets, catalogues, brochures, posters and guide booklets, exhibition stands, virtual social networks and websites. Art. 1(c) defines medical equipment as everything covered by the Medical Equipment Regulation approved in 1386 by the Ministry of Health, Treatment and Medical Education and its subsequent amendments.

The use of comparative and superlative adjectives — the best, the most superior, the first, the best-equipped and similar — in advertising is prohibited (Art. 14, a general provision that applies to all advertising within the Directive's scope, including medical-equipment advertising under Art. 4). Separately, within the provisions governing the advertising of medical practices, offices and institutions (Arts. 20–24), Art. 23 permits publishing film or images of the practice premises but prohibits the publication in such advertising of an image of medical equipment that identifies a particular brand; the Directive does not state that this brand-image prohibition extends to advertising placed by device manufacturers or distributors.

IRC codes have limited validity and lapse with the underlying authorization: an expired IRC is rejected in the comprehensive code system, expiry of the product's پروانه ساخت ends its IRC, and IRCs of companies that fail to file amendments (اصلاحیه) are expired — reinstated only after filing the amendment and paying the goods-registration and source-registration fees (هزینه ثبت کالا و ثبت منبع).

The پروانه ساخت is issued for a definite period and is renewed after review of continued production conditions; renewal assessment covers production statistics, complaint and quality-problem records and their resolution, discharge of commitments taken at initial issuance or last renewal, validity of the mandatory-standard certificate for covered products, and closure of non-conformities found in surveillance assessments (ارزیابی‌های مراقبتی).

Iran Food and Drug Administration (سازمان غذا و دارو, IFDA) regulates medical devices; the national operating unit is its General Directorate of Medical Equipment and Supplies (اداره کل تجهیزات و ملزومات پزشکی), known as IMED, which licenses and supervises manufacture, import, distribution and after-sales activities.

The Iran FDA (سازمان غذا و دارو) operates under the Ministry of Health and Medical Education (وزارت بهداشت، درمان و آموزش پزشکی); the ministry and FDA identities are displayed together on the FDA's TTAC system.

IFDA delegates execution to the food and drug deputies of medical-sciences universities: risk-class A/B manufacturing licenses are issued and renewed by university deputies (e.g., Isfahan UMS), and review/issuance of IRC codes for such items is delegated to selected universities.

If the declared use of a laboratory item changes from research-only to in-vitro diagnostic (IVD), the product must be registered in the directorate's registration system and comply with device requirements — the RUO exemption ends.

Diagnostic laboratory (IVD) kits undergo the directorate's evaluation protocols — both qualitative (پروتکل ارزیابی کیفی کیت‌های تشخیص آزمایشگاهی) and quantitative (پروتکل ارزیابی کمی) — as part of the licensing dossier.

Laboratory items whose declared field of use is 'research only' are NOT medical devices under Article 1 note (چ) of the medical-equipment regulation and need no license from the Medical Equipment Directorate, provided the label and brochure clearly state 'فقط برای مصارف پژوهشی و تحقیقاتی' or 'Research Use Only'.

Dossier for a class A/B پروانه ساخت: company articles (اساسنامه شرکت); technical-officer credential; technical file per the issuance/renewal directive; commitment to prepare and retain the technical file; safety and performance test reports from the directorate's cooperating laboratories; suitable production environment; QMS implementation evidenced by an ISO 13485 certificate.

Foreign manufacturers act through an Iranian company: the directorate's official process 'راهنمای تشکیل شناسنامه و ثبت نمایندگی کمپانی‌های خارجی' (guide to forming the company profile and registering the representation of foreign companies) governs registration of the foreign manufacturer's representation; import authorizations are held by the licensed Iranian importer.

Manufacturers must have a مسئول فنی (technical officer) whose competence is approved by the Medical Equipment Commission (Article 6 of the medical-equipment regulation); the technical officer supervises quality-system execution across production, ordering, quality control, storage, hygiene and safety, training and records; legal responsibility for production under the license rests on the CEO and the technical officer.

Distribution and retail of medical equipment require an establishment/activity permit under the directive 'دستورالعمل تأسیس و فعالیت شرکت‌های پخش، توزیع و عرضه تجهیزات و ملزومات پزشکی', plus a defined registration process for distributors/suppliers and storage under the storage-and-warehousing directive (دستورالعمل انبارش و نگهداری).

Under Article 47 of the medical-equipment regulation, import of all used and second-hand medical equipment for sale, use or consumption is prohibited. Devices refurbished by (or authorized by) the original manufacturer may be imported subject to issued directives and Technical Committee approval; the list of refurbishable items is set annually. No refurbished IVD device has ever been approved.

Devices carry the tracking/authenticity label under the 'بخشنامه برچسب اصالت' published on imed.ir (path: imed.ir > ادارات > نظارت و ارزیابی (بازرسی) > اصالت کالا); label executors connect to the central system per Annex 3 protocol, and companies submit XML tracking-label files through the system (pre-payment steps require the CEO-level account).

For research-use laboratory items, the company must print 'فقط برای مصارف پژوهشی و تحقیقاتی' or 'Research Use Only' clearly and visibly on the label and brochure.

The earlier 'آیین‌نامه تجهیزات پزشکی' remains applied for specific provisions: Article 47 (used-device import ban), Article 1 note (چ) (scope/RUO borderline) and Article 6 (Medical Equipment Commission approving technical officers) are cited by IFDA university offices in official guidance.

Device manufacturing licensing rests on: (1) Law on Medical, Pharmaceutical and Food Affairs (قانون مربوط به امور پزشکی و دارویی و مواد خوردنی و آشامیدنی); (2) Regulation on Activity in the Medical Equipment Sector (آیین‌نامه فعالیت در حوزه تجهیزات پزشکی); (3) Directive on Issuance and Renewal of Manufacturing Licenses (دستورالعمل صدور و تمدید پروانه ساخت تجهیزات و ملزومات پزشکی); (4) Directive on Storage and Warehousing (دستورالعمل انبارش و نگهداری تجهیزات و ملزومات پزشکی).

License renewal requires post-market evidence: production statistics (آمار تولید), complaint and quality-problem documentation and resolution (مدارک و مستندات رفع شکایات و مشکلات کیفی), discharge of prior commitments, valid mandatory-standard license for covered products, and closure of non-conformities observed in surveillance assessments (ارزیابی‌های مراقبتی).

Two official systems carry the process: the IMED portal (imed.ir) for company, product, import and distribution processes and the e-service desk; and TTAC — سامانه تیتک (ttac.ir) — the FDA-wide identity, registration-code and track-and-trace system, with XML tracking-label file support handled through support.ttac.ir.

Quality-management certification bodies for medical equipment are vetted and published by the directorate; the imed.ir site maintains the list 'موسسات صدور گواهینامه سیستم مدیریت کیفیت (CB)' as a cooperating-institution category.

Implementation of a quality-management system evidenced by an ISO 13485 certificate is a licensing requirement for device manufacturing.

TTAC provides a rapid-reaction and recall system for non-conforming health products nationwide; the directorate also publishes recalls ('فراخوان - Recall') and safety notices/alerts (اطلاعیه‌ها و هشدارهای ایمنی) as public sections on imed.ir.

Domestic manufacture of a device requires a manufacturing license (پروانه ساخت) under the 'دستورالعمل صدور و تمدید پروانه ساخت تجهیزات و ملزومات پزشکی'; for risk classes A and B the whole application, tracking and issuance process is electronic.

Placing imported devices on the market runs through the registered Iranian importing company: the directorate requires identification (شناسه‌گذاری) of all medical equipment by importing companies; until identification is done the item's IRC is deactivated, hidden from the imed.ir site, and removed from the list sent to the Central Bank for currency allocation.

Submission Surface

IMED portal (imed.ir) of the IFDA General Directorate of Medical Equipment & Supplies for company/product/import processes; TTAC (ttac.ir) for identity, registration codes and track-and-trace; class A/B manufacturing-license applications are filed electronically via imed.ir with university food and drug deputies.

Verified Highlights

• The national medical-device operational surface is the IMED portal, with TTAC as the FDA-wide identity/track-and-trace system.
• License application, tracking and issuance are fully electronic.

Caveat

The imed.ir homepage content served during review is dated 1401 (2022); current-generation portal URLs (e.g., import.imed.ir) could not be opened for https verification.

A dedicated process exists for research-use goods: 'فرآیند صدور کد irc کالاهای تحقیقاتی' (process for issuing IRC codes for research goods) with a research-goods registration guide.

The directorate operates a 'مجوز فروش موقت' (temporary sale permit) category, published as a public inquiry section on imed.ir alongside the other license inquiries.

All steps of application, tracking and issuance of the manufacturing license are electronic; the official service charter shows the internet channel (through imed.ir) as the sole enabled service channel.

Questions on tracking-label XML files are submitted as tickets to the FDA support system at support.ttac.ir (section 'مشکلات فایل‌های شناسه رهگیری و ردیابی (XML)') and are answered within 48 hours.

Product registration in the directorate's system uses GS1 GTIN codes; product variants are registered in a mother-child (مادری-فرزندی) structure, adding each distinguishing item under the parent record's 'افزودن GTIN' function.

All medical equipment and supplies must be identified (شناسه‌گذاری) by importing and manufacturing companies; until identification is done the item's IRC is deactivated and not shown on imed.ir, currency allocation processing for the IRC stops, and the IRC is removed from the list sent to the Central Bank.

TTAC (Track & Trace & Authentication Control) is the FDA system creating a tracking and tracing regime for health products — including medical equipment and supplies — along the whole supply chain, with public authenticity checking of products.

The directorate operates the MDR quality-problem reporting channel ('گزارش مشکلات کیفی MDR') on imed.ir, with a dedicated user guide ('راهنمای مشکلات کیفی MDR'), alongside safety notices and alerts sections; complaint handling runs under the defined process 'فرآیند رسیدگی به شکایات تجهیزات پزشکی'.