Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
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FDA Apostille for Colombia
FDA Apostille for Colombia
Colombia has applied the Hague Apostille Convention since 30 January 2001, and INVIMA expects foreign public documents to carry an apostille. Your FDA export certificate needs one U.S. Department of State apostille, with no Colombian consulate legalization. Upload the digital certificate and we return it apostilled by FedEx, ready for your INVIMA file.
- Hague membersince 30 January 2001
- Apostilledocument route
- Spanishofficial language
- 9 daysstandard processing
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time 9 business days
- No document shipping is required.
- You may update your own FedEx AWB or create a new one.
- Expedited processing times are offered.
- Credit card payments are accepted.
- The U.S. Department of State fee is already included.
- No separate U.S. Department of State form is needed.
- Track your order history and expenditures online.
Exp. Service fee$68 / Doc.
US Dept. of State fee$20 / Doc.
Total:$88 / Doc.
Why Colombia Asks for an Apostilled FDA Certificate
INVIMA, Colombia's National Institute for Food and Drug Surveillance, regulates medicines, medical devices, food, supplements and cosmetics. In its legal opinion Concepto 183 of 2021, it confirmed that public documents from Hague Convention countries must be apostilled to be accepted in its procedures, under Law 455 of 1998, which brought the Convention into Colombian law.
An FDA certificate is a U.S. federal public document, so it is apostilled by the U.S. Department of State. That's different from a free sale certificate issued by a U.S. state or a private body, which follows its own route. We take care of the State Department step for your FDA certificate and ship it to you or straight to your Colombian registration holder.
Which FDA Certificate Does Your Colombian Importer Need?
Match your product to the Colombian authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Colombian authority | FDA certificate |
|---|---|---|
| Medicines | INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | INVIMA, Medical Devices directorate | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food, ingredients & infant formula | INVIMA, with registration, permit or notification depending on risk | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements & medical foods | INVIMA | Certificate of Free Sale (CFS) |
| Cosmetics & personal care | INVIMA, applying Andean Community (CAN) notification rules | Certificate for Cosmetics |
INVIMA covers every product group, but the procedure varies. Food is classified by risk, and cosmetics follow Andean Community notification rules shared with Ecuador, Peru and Bolivia. Your Colombian registration holder will confirm the certificate INVIMA expects.
How the FDA Apostille for Colombia Works
The Hague Apostille Convention has been in force for Colombia since 30 January 2001, so a single apostille from the U.S. Department of State makes your FDA certificate valid there. There is no embassy visit, consular stamp or second legalization step.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Colombia as the destination.
We review it
We check that the certificate is complete, FDA-signed and ready for the State Department.
State Department apostille
We submit it to the Office of Authentications and track it until the apostille is issued.
FedEx delivery
The apostilled certificate ships to you, your importer or your agent in Bogotá or anywhere else.
Exporting to Colombia: What to Prepare
FDA certificate or state certificate?
Some exporters use a free sale certificate issued by their U.S. state, or by a private body authorized by the state. INVIMA has explained that those documents follow a different route, through notary and state-level apostille. An FDA-issued certificate is federal, so it goes to the U.S. Department of State. Tell us which one you have and we'll confirm the right process.
Official Spanish translation
INVIMA works in Spanish, and foreign documents are generally submitted with an official translation by a certified translator. Have the FDA certificate apostilled first and translated afterwards, so the translation also covers the apostille.
A Colombian registration holder
Registrations are held by a company in Colombia, usually your importer or distributor, which files through INVIMA's systems. Make sure the manufacturer and product names on your FDA certificate match its application.
Andean and Pacific plans
Colombia is often the first Andean market for U.S. brands, followed by Ecuador and Peru. All three accept apostilles, and cosmetics share Andean notification rules, but each authority still wants its own apostilled original. Order one per country.
FDA Apostille Cost for Colombia
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $68 / doc. | Review, submission, tracking and FedEx dispatch |
| U.S. Department of State fee | $20 / doc. | Paid by us on your behalf |
| Total | $88/ doc. | Standard processing: 9 business days. Expedited options available. |
FDA Apostille for Colombia: FAQs
Is Colombia a member of the Hague Apostille Convention?
Yes. Colombia joined by accession, and the Convention has applied there since 30 January 2001. A U.S. Department of State apostille is enough, so no Colombian consulate legalization is required.
Does INVIMA require an apostilled FDA certificate?
Yes. In Concepto 183 of 2021, INVIMA confirmed that public documents from Hague Convention countries must be apostilled to be accepted in its procedures, under Law 455 of 1998. FDA certificates are U.S. public documents, so they need a State Department apostille.
Can I use a state-issued free sale certificate instead?
Some exporters do, but it follows a different legalization route, usually through notary and state-level apostille. An FDA-issued certificate is federal and is apostilled by the U.S. Department of State. Confirm with your registration holder which certificate INVIMA expects for your product.
Does my FDA certificate need an official Spanish translation?
Usually yes. INVIMA works in Spanish, and foreign documents are generally filed with an official translation. Translate after the apostille is attached.
Which FDA certificate do I need for INVIMA?
A CPP for medicines, a CFG for medical devices and conventional foods, a Certificate of Free Sale for dietary supplements, and a Certificate for Cosmetics for cosmetic products, which follow Andean rules. Products not sold in the U.S. need a Certificate of Exportability.
How long does an FDA apostille for Colombia take and what does it cost?
Standard processing takes 9 business days and costs $88per document: our $68 service fee plus the $20 U.S. Department of State fee. Expedited options are available.
FDA Certificates We Apostille for Colombia
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.
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Get Your FDA Certificate Apostilled for Colombia
Upload your FDA certificate today and receive it apostilled by FedEx in 9 business days, for $88per document with the State Department fee included.
Start Your Order Ask a Question
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time
9 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
Total:
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