Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
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FDA Embassy Legalization for Sri Lanka
FDA Embassy Legalization for Sri Lanka
Sri Lanka is not a party to the Hague Apostille Convention, so FDA certificates for its National Medicines Regulatory Authority (NMRA) must be legalized. We have the certificate authenticated by the U.S. Department of State and legalized by the Embassy of Sri Lanka in Washington, then FedEx it to you or your local agent in Colombo in about 33 business days.
- Not in Hagueembassy legalization needed
- Two-step legalizationdocument route
- Sinhala and Tamil (English widely used)official language
- 33 daysstandard processing
Prepare Your Sri Lanka FDA Certificate
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
Processing time 33 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 Sri Lanka fee$60 / Doc.
Total:$200 / Doc.
FedEx return shipping is available for completed documents.
See expedited options →Why Sri Lanka Asks for a Legalized FDA Certificate
Medicines, medical devices and borderline products in Sri Lanka are regulated by the NMRA under the National Medicines Regulatory Authority Act, No. 5 of 2015, which replaced the Cosmetics, Devices and Drugs Act of 1980. The NMRA registers and licenses products, controls their manufacture and import, and oversees clinical trials. Foreign manufacturers apply through a marketing authorization holder in Sri Lanka, appointed by a letter of authorization from the legal manufacturer.
Device dossiers must include a valid free sale certificate, and the original, or an online verification such as a QR code, has to be presented when the processing fee is paid. New products first receive a provisional registration of one or two years, followed by full registration for five years. For U.S. products, the free sale proof is an FDA certificate, legalized by the Embassy of Sri Lanka before the NMRA sees it.
Which FDA Certificate Does Your Sri Lankan Importer Need?
Match your product to the Sri Lankan authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Sri Lankan authority | FDA certificate |
|---|---|---|
| Medicines | National Medicines Regulatory Authority (NMRA), Act No. 5 of 2015 | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | NMRA, Medical Devices Regulatory division | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | Ministry of Health, under the Food Act | Certificate to a Foreign Government (CFG), Health Certificate |
| Borderline products & supplements | NMRA, borderline products division | Certificate of Free Sale (CFS) |
| Cosmetics | Sri Lankan health and standards authorities; confirm with your agent | Certificate for Cosmetics |
The NMRA handles medicines, devices and borderline products such as some supplements, while food falls under the Ministry of Health's food control system. Your Sri Lankan agent will confirm which FDA certificate each file needs.
How FDA Embassy Legalization for Sri Lanka Works
Sri Lanka 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 Sri Lanka.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Sri Lanka 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 Sri Lanka for legalization, which takes about 24 business days.
FedEx delivery
The legalized certificate ships to you, your importer or your agent in Colombo or anywhere else.
Exporting to Sri Lanka: What to Prepare
The longest embassy step
The Embassy of Sri Lanka step takes about 24 business days, so the whole process runs to roughly 33 business days. Order well before any NMRA submission or renewal deadline.
Provisional, then full registration
New devices usually start with a one- or two-year provisional registration before full five-year registration, and import licenses are renewed yearly. Keep legalized FDA certificates current for each stage.
Weekly dossier days
The NMRA accepts device dossiers on Tuesdays at its dossier accepting point, and replies to queries are due within two months. Have your legalized documents ready before booking a submission.
Renew six months ahead
Registration renewals must be filed six months before expiry. Because legalization takes over a month, order fresh certificates early in that window.
FDA Embassy Legalization Cost for Sri Lanka
| 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 Sri Lanka fee | $60 / doc. | Embassy legalization, about 24 business days. Paid by us on your behalf |
| Total | $200/ doc. | Standard processing: 33 business days. Expedited options available. |
FDA Embassy Legalization for Sri Lanka: FAQs
Does Sri Lanka accept apostilles?
No. Sri Lanka 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 Sri Lanka.
Why does FDA legalization for Sri Lanka take 33 business days?
The Embassy of Sri Lanka step takes about 24 business days, on top of roughly 9 at the State Department. FedEx delivery follows.
How much does it cost?
$200per document, combining our $120 service fee, the $20 State Department fee and the $60 Embassy of Sri Lanka fee.
Who regulates medicines and devices in Sri Lanka?
The National Medicines Regulatory Authority (NMRA), under Act No. 5 of 2015, which registers medicines, devices and borderline products.
Do I need a local agent in Sri Lanka?
Yes. Foreign manufacturers apply through a marketing authorization holder in Sri Lanka, appointed with a letter of authorization.
Which FDA certificate does Sri Lanka need?
NMRA files typically use 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 Sri Lanka
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 Sri Lanka
Upload your FDA certificate today and receive it legalized by FedEx in 33 business days, for $200per 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
33 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 Sri Lanka fee
Total:
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