Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
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FDA Embassy Legalization for Iran
FDA Embassy Legalization for Iran
Iran is not a party to the Hague Apostille Convention and has no embassy in the United States. FDA certificates for use in Iran are authenticated by the U.S. Department of State and then legalized by the Interests Section of the Islamic Republic of Iran, which operates under the Embassy of Pakistan in Washington. We handle both steps and return the document by FedEx in about 19 business days.
- Not in Hagueembassy legalization needed
- Two-step legalizationdocument route
- Persian (Farsi)official language
- 19 daysstandard processing
Prepare Your FDA Certificate for Iran
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
Processing time 19 business days
- We accept credit card payments.
- Track your order history and expenses online.
- U.S. Department of State and Interests Section fees are already included.
- Submit the files you received from the FDA electronically.
- We use the State Department minimum processing time.
- You may update your own FedEx air waybill or purchase a new one.
- U.S. Department of State Form DS-4194 is not required; we handle it.
Exp. Service fee$120 / Doc.
U.S. Department of State fee$20 / Doc.
Iran Interests Section fee$575 / Doc.
Total:$715 / Doc.
FedEx return shipping is available for completed documents after processing.
See expedited options →Why Iran Asks for a Legalized FDA Certificate
Diplomatic relations between the United States and Iran ended in 1980, and since 1992 Pakistan has acted as Iran's protecting power in Washington. Iran's consular work in the U.S. is carried out by its Interests Section, which provides the final legalization stamp that would otherwise come from an embassy. Because the office keeps limited public hours, its step takes longer than most embassies, around 10 business days.
Health products in Iran are regulated by the Iran Food and Drug Administration (IFDA) under the Ministry of Health and Medical Education, which oversees medicines, medical devices, food and cosmetics. On the U.S. side, exports are governed by OFAC's Iranian Transactions and Sanctions Regulations. A general license at 31 CFR 560.530, expanded in December 2016, authorizes exports of medicine and most medical devices, but some devices on OFAC's specific-license list still need individual authorization.
Which FDA Certificate Does Your Iranian Importer Need?
Match your product to the Iranian authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Iranian authority | FDA certificate |
|---|---|---|
| Medicines | Iran Food and Drug Administration (IFDA), Ministry of Health and Medical Education | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | IFDA's medical equipment authority, Ministry of Health and Medical Education | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | IFDA | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements | IFDA | Certificate of Free Sale (CFS) |
| Cosmetics | IFDA | Certificate for Cosmetics |
IFDA regulates medicines, devices, food, supplements and cosmetics under the Ministry of Health and Medical Education. Your Iranian counterpart will confirm which FDA certificate the file needs.
How FDA Embassy Legalization for Iran Works
Iran is not a party to the Hague Apostille Convention, and it has no embassy in the United States. Your FDA certificate is first authenticated by the U.S. Department of State, then legalized by the Interests Section of the Islamic Republic of Iran, which operates under the Embassy of Pakistan in Washington.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Iran as the destination.
U.S. Department of State
The State Department authenticates the FDA official's signature in about 9 business days.
Interests Section of Iran
The Interests Section legalizes the authenticated certificate, which takes about 10 business days.
FedEx delivery
The legalized certificate ships to you or to the address you designate.
Exporting to Iran: What to Prepare
Confirm OFAC authorization first
Exports of medicine and most medical devices to Iran fall under OFAC's general license at 31 CFR 560.530, while devices on OFAC's specific-license list require individual authorization. Confirm your product's status and screen all parties before shipping, and take advice if you're unsure.
Legalization is not export permission
A legalized FDA certificate proves your product's U.S. status to Iranian authorities. It does not replace any U.S. export authorization, which remains your responsibility as the exporter.
Allow extra time
The Interests Section step takes about 10 business days, so the whole process runs to roughly 19 business days. Order early when an Iranian registration or tender has a deadline.
Persian translations
Persian (Farsi) is Iran's official language. Iranian authorities generally expect a certified Persian translation of foreign documents, made after legalization so the stamps are covered.
FDA Embassy Legalization Cost for Iran
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $120 / doc. | Review, submission, tracking and FedEx dispatch |
| U.S. Department of State fee | $20 / doc. | State Department authentication, about 9 business days |
| Iran Interests Section fee | $575 / doc. | Legalization by the Interests Section of Iran, about 10 business days. Paid by us on your behalf |
| Total | $715/ doc. | Standard processing: 19 business days. Expedited options available. |
FDA Embassy Legalization for Iran: FAQs
Does Iran accept apostilles?
No. Iran is not a party to the Hague Apostille Convention. FDA certificates are authenticated by the U.S. Department of State and then legalized by the Interests Section of Iran.
Is there an Iranian embassy in the United States?
No. Iran's consular affairs in the U.S. are handled by the Interests Section of the Islamic Republic of Iran, which operates under the Embassy of Pakistan in Washington, D.C.
How long does FDA legalization for Iran take?
About 19 business days: roughly 9 at the State Department and 10 at the Interests Section of Iran, followed by FedEx delivery.
How much does it cost?
$715per document: our $120 service fee, the $20 State Department fee and the $575 Interests Section fee.
Can U.S. companies export medicines and medical devices to Iran?
Generally yes, under OFAC's general license at 31 CFR 560.530, except for devices on OFAC's list requiring specific authorization. Legalizing an FDA certificate does not replace that authorization.
Which FDA certificate does Iran need?
IFDA files typically rely on a CPP for medicines, a CFG for devices and foods, a Certificate of Free Sale for supplements and a Certificate for Cosmetics for cosmetic products. Products not sold in the U.S. need a Certificate of Exportability.
FDA Certificates We Legalize for Iran
Certificate to a Foreign Government (CFG)
Medical devices, conventional foods, food additives and infant formula sold in the U.S.
Certificate of a Pharmaceutical Product (CPP)
The WHO-format certificate used to register human drugs.
Certificate of Exportability
Products made in the U.S. for export only.
Health Certificate
Collagen and gelatin exports (EU health certificate or SRM certificate).
Certificate for Cosmetics
Skincare, makeup, haircare and fragrance products.
Nearby destinations
Get Your FDA Certificate Legalized for Iran
Upload your FDA certificate today and receive it legalized by FedEx in 19 business days, for $715per document with State Department and Interests Section fees included.
Start Your Order Ask a Question
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time
19 business days
- We accept credit card payments.
- Track your order history and expenses online.
- The U.S. Department of State fee is already included.
- Submit the files you received from the FDA electronically.
- We use the State Department minimum processing time.
- You may update your own FedEx air waybill or purchase a new one.
- U.S. Department of State Form DS-4194 is not required; we handle it.
Exp. Service fee
Embassy of Iran fee
US Dept. of State fee
Total:
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