Iran has an established product compliance system based on national standards, mandatory certifications, and sector-specific regulations. While not aligned with EU or U.S. systems due to sanctions, Iran maintains a comprehensive framework through its own institutions to regulate industrial goods, food, pharmaceuticals, telecom, and consumer products.

Key Authorities:

• Institute of Standards and Industrial Research of Iran (ISIRI) – Develops national standards and enforces conformity assessment programs. Many products require ISIRI certification prior to import or sale.

• Iran Food and Drug Administration (IFDA) – Regulates food, beverages, cosmetics, pharmaceuticals, and medical devices, including import licensing and product registration.

• Communications Regulatory Authority (CRA) – Oversees type approval for telecommunications, wireless, and RF devices. Testing and approval are mandatory for many electronic products.

• Iran Customs Administration (IRICA) – Enforces import documentation, tariff classification, and coordination with regulatory bodies at borders.

• National Medical Device Directorate (IMED) – A division under the Ministry of Health that manages the registration and market surveillance of medical devices.

Key Compliance Elements:

• ISIRI Certification:

  • Products under ISIRI control (e.g., electrical appliances, auto parts, gas products) must obtain ISIRI marks. Certification involves submission of technical documents and samples for evaluation.

  • Some items are exempt if covered under recognized international standards and bilateral agreements.

• Product Registration:

  • IFDA registration is mandatory for all food, beverages, drugs, cosmetics, and dietary supplements.

  • IMED registration is required for medical equipment, and includes classification, safety evaluation, and labeling review.

• CRA Type Approval:

  • Required for telecom and wireless products (e.g., smartphones, modems, radio equipment).

  • Approval involves local testing or documentation evaluation and results in a CRA registration number and import clearance eligibility.

• Labeling Requirements:

  • Must be in Persian (Farsi) and include:

    • Product name

    • Manufacturer/importer contact

    • Usage instructions

    • Certification or registration code

    • Production/expiry date (if applicable)

    • Safety warnings and country of origin

• Import Control:

  • Imports require order registration (sabte sefaresh) with the Ministry of Industry.

  • Documents include commercial invoice, packing list, ISIRI/IFDA/CRA certificate (where applicable), and certificate of origin.