Iran medical device registration resources

Competent authority

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 تجه…

Ministry anchoring of the regulator

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 t…

Statutory bases for device licensing

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…

Legacy medical-equipment regulation still applied

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 Equipmen…

Research-use laboratory items outside device scope

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 Equ…

No source-verified answer is published for this dimension yet.

Import route: identification and IRC control

Placing imported devices on the market runs through the registered Iranian importing company: the directorate requires identification (شناسه‌گذاری) of all medical equipment by importing com…

Market-access route or official registration surface

submissionSurface: IMED portal (imed.ir) of the IFDA General Directorate of Medical Equipment & Supplies for company/product/import processes; TTAC (ttac.ir) for identity, registration code…

Mutual-recognition MOUs (Oman, Qatar, Syria)

IFDA's Medical Equipment Directorate has signed cooperation MOUs on mutual recognition of the registration process for drugs and medical/laboratory equipment with Oman and Qatar, and a mutu…

Technical officer (مسئول فنی) requirement

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 offic…

Foreign company representation registration

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 r…

Ban on import of used devices; refurbishment exception

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…

Distribution establishment licensing

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', plu…

Class A/B manufacturing-license dossier

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…

Official systems: IMED and TTAC

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…

Mandatory RUO statement on label and brochure

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.

Authenticity (برچسب اصالت) label scheme and XML protocol

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…

ISO 13485 requirement for manufacturing license

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

IFDA-vetted certification bodies (CB)

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)…

Manufacturing-license test reports and ISO 13485

Electrical safety

Mandatory-standard licence at renewal

Product-specific

Manufacturing licence - issuance

IRR 2,820,000

Manufacturing licence - renewal

IRR 840,000

No source-verified answer is published for this dimension yet.

Manufacturing license has definite validity and renewal review

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 proble…

IRC validity, expiry and reinstatement

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, a…

Intended-use change from research to IVD triggers registration

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 dev…

Mandatory identification (شناسه‌گذاری) of all devices

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 ime…

TTAC nationwide track-and-trace and authentication

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 suppl…

IVD kit evaluation protocols

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

IRC process for research goods

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.

Temporary sale permit (مجوز فروش موقت)

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.

PMS evidence required at license renewal

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), dis…

MDR quality-problem reporting system

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 an…

Recall capability and public recall notices

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 (اطلاعیه‌…

No source-verified answer is published for this dimension yet.

Fully electronic submission and tracking

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 se…

TTAC support response within 48 hours

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 4…