Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Embassy Legalization for Eritrea
FDA Embassy Legalization for Eritrea
Eritrea has not joined the Hague Apostille Convention, so FDA certificates used in Eritrea need embassy legalization. Our team takes the certificate through U.S. Department of State authentication and then legalization by the Embassy of the State of Eritrea in Washington, and FedExes it to you or your partner in Asmara in about 14 business days.
- Not in Hagueembassy legalization needed
- Two-step legalizationdocument route
- Tigrinya, Arabic and English (working languages)official language
- 14 daysstandard processing
Begin Your Eritrea FDA Legalization
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
Processing time 14 business days
- We accept credit card payments.
- Track your order history and expenses online.
- U.S. Department of State and embassy 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.
US Dept. of State fee$20 / Doc.
Embassy of Eritrea fee$50 / Doc.
Total:$190 / Doc.
FedEx return shipping is available for completed documents after processing.
See expedited options →Why Eritrea Asks for a Legalized FDA Certificate
Medicines, medical devices and food in Eritrea are regulated by the National Medicines and Food Administration (NMFA) of the Ministry of Health in Asmara. Products are registered before they are procured, and NMFA reviews the dossier submitted by the applicant. Eritrea also signed a participation agreement for the WHO Collaborative Registration Procedure on 2 May 2017, which lets NMFA draw on WHO prequalification assessments when registering qualifying medicines.
In 2019, NMFA held a consensus workshop on a national medical device registration guideline adapted from Global Harmonization Task Force principles. It covers devices and in-vitro diagnostics by risk level and asks applicants to submit complete dossiers, because, in NMFA's words, incomplete submissions and slow responses cause unnecessary delays. A legalized FDA certificate is one of the simplest ways to make a U.S. product's file complete.
Which FDA Certificate Does Your Eritrean Importer Need?
Match your product to the Eritrean authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Eritrean authority | FDA certificate |
|---|---|---|
| Medicines | National Medicines and Food Administration (NMFA), Ministry of Health | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices & IVDs | NMFA, risk-based registration guideline | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | NMFA | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements | NMFA, as food or medicine depending on classification | Certificate of Free Sale (CFS) |
| Cosmetics | Ministry of Health; confirm the current route with your partner | Certificate for Cosmetics |
NMFA handles medicines, devices and food under the Ministry of Health. Your Eritrean partner or procurement contact will confirm which FDA certificate the file needs before you order.
How FDA Embassy Legalization for Eritrea Works
Eritrea is not a party to the Hague Apostille Convention, so it does not accept apostilles. Your FDA certificate is first authenticated by the U.S. Department of State and then legalized by the Embassy of Eritrea.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Eritrea as the destination.
State Department authentication
We submit it to the Office of Authentications, which issues the federal authentication certificate in about 9 business days.
Embassy legalization
We take the authenticated certificate to the Embassy of Eritrea for legalization, which takes about 5 business days.
FedEx delivery
The legalized certificate ships to you, your importer or your agent in Asmara or anywhere else.
Exporting to Eritrea: What to Prepare
Registration before procurement
NMFA expects products to be registered before they are procured, so legalized FDA certificates belong at the very start of a deal, not at shipment. Build the legalization time into any tender or supply timeline.
WHO collaborative registration
Because Eritrea participates in the WHO Collaborative Registration Procedure, WHO-prequalified medicines may move through registration faster. Ask your partner whether your product qualifies and which national documents are still required.
Complete dossiers avoid delays
NMFA has stressed that incomplete submissions and late answers to queries are the main causes of delay. Send complete, matching documents the first time, with company and product names identical across every certificate.
Working in English
Eritrea uses Tigrinya, Arabic and English as working languages, and English is widely used in official health documentation. Your partner will tell you if any translation is needed.
FDA Embassy Legalization Cost for Eritrea
| 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 |
| Embassy of Eritrea fee | $50 / doc. | Embassy legalization, about 5 business days. Paid by us on your behalf |
| Total | $190 / doc. | Standard processing: 14 business days. Expedited options available. |
FDA Embassy Legalization for Eritrea: FAQs
Does Eritrea accept apostilles?
No. Eritrea is not a party to the Hague Apostille Convention, so FDA certificates need U.S. Department of State authentication followed by legalization at the Embassy of Eritrea.
How long does FDA embassy legalization for Eritrea take?
About 14 business days: roughly 9 at the State Department and 5 at the Embassy of Eritrea, followed by FedEx delivery.
How much does it cost?
The total is $190 per document, combining our $120 service fee with the $20 State Department fee and the $50 fee charged by the Embassy of Eritrea.
Who regulates medicines in Eritrea?
The National Medicines and Food Administration (NMFA) of the Ministry of Health, which registers medicines, medical devices and food products.
Does Eritrea take part in WHO collaborative registration?
Yes. Eritrea signed a participation agreement for the WHO Collaborative Registration Procedure on 2 May 2017, which can speed up registration of WHO-prequalified medicines.
Which FDA certificate does Eritrea need?
For an NMFA file, medicines are normally supported by a CPP, devices and foods by a CFG, supplements by a Certificate of Free Sale and cosmetics by a Certificate for Cosmetics. A Certificate of Exportability covers products not sold in the U.S.
FDA Certificates We Legalize for Eritrea
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 Eritrea
Upload your FDA certificate today and receive it legalized by FedEx in 14 business days, for $190 per document with State Department and embassy 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
14 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
US Dept. of State fee
Embassy of Eritrea fee
Total:
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