Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Apostille for Mexico
FDA Apostille for Mexico
Mexico has accepted apostilles since 14 August 1995, and COFEPRIS expects foreign certificates to carry one. Your FDA export certificate needs a single U.S. Department of State apostille, with no Mexican consulate legalization. Upload the digital certificate and we return it apostilled by FedEx, ready for your registro sanitario file.
- Hague membersince 14 August 1995
- 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 Mexico Asks for an Apostilled FDA Certificate
Mexico is the largest export market for many U.S. health and consumer brands, and almost every registration starts with COFEPRIS, the Federal Commission for the Protection against Sanitary Risks. For imported medical devices, for example, COFEPRIS asks for a certificate of free sale (or equivalent) from the health authority of the country of origin. Its rules state that documents issued by foreign authorities must be apostilled and translated by an expert translator (perito traductor).
For U.S. products, that certificate comes from the FDA. The FDA is a federal agency, so its certificates are apostilled only by the U.S. Department of State, not by a U.S. state. We prepare and track the State Department request and ship the apostilled certificate to you or straight to your Mexican registration holder.
Which FDA Certificate Does Your Mexican Importer Need?
Match your product to the Mexican authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Mexican authority | FDA certificate |
|---|---|---|
| Medicines | COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | COFEPRIS, registro sanitario de dispositivos médicos | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food, ingredients & infant formula | COFEPRIS | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements & medical foods | COFEPRIS (suplementos alimenticios) | Certificate of Free Sale (CFS) |
| Cosmetics & personal care | COFEPRIS, under Mexican labeling standards (NOM) | Certificate for Cosmetics |
COFEPRIS regulates all of these categories, but not every product needs a full sanitary registration. Some need only an import permit or must meet labeling standards. Your Mexican registration holder or customs agent will confirm the route and the exact certificate COFEPRIS expects.
How the FDA Apostille for Mexico Works
The Hague Apostille Convention has been in force for Mexico since 14 August 1995, 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 Mexico 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 Mexico City or anywhere else.
Exporting to Mexico: What to Prepare
Apostille first, then the perito traductor
COFEPRIS requires foreign-authority documents to be apostilled and then translated into Spanish by a perito traductor, an expert translator authorized in Mexico. Always apostille the FDA certificate before it is translated, so the apostille is part of the official translation.
A Mexican registration holder
Registrations are filed by a company in Mexico that holds the registro sanitario and has a responsable sanitario on staff. If the U.S. manufacturer isn't the applicant, COFEPRIS also expects a representation letter. Make sure the names on the FDA certificate match both.
GMP evidence alongside the certificate
For medical devices, COFEPRIS also asks for a good manufacturing practices certificate from the authority of the country of origin. Plan both documents together so your file isn't held up waiting for one of them.
USMCA supply chains
U.S.–Mexico trade runs under the USMCA, and many U.S. companies ship to Mexico through distributors who also serve Central America. If the same certificate will support filings in Guatemala or Colombia too, order a separate apostilled original for each country.
FDA Apostille Cost for Mexico
| 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 Mexico: FAQs
Is Mexico a member of the Hague Apostille Convention?
Yes. Mexico joined by accession, and the Convention has applied there since 14 August 1995. A U.S. Department of State apostille is enough, so no Mexican consulate legalization is needed.
Does COFEPRIS require an apostilled FDA certificate?
For many registrations, yes. COFEPRIS's rules require documents issued by foreign authorities, such as an FDA certificate of free sale, to be apostilled or legalized and translated into Spanish by a perito traductor.
What is a perito traductor and when should the translation be done?
A perito traductor is an expert translator authorized in Mexico whose translations COFEPRIS accepts. Have the FDA certificate apostilled first, then translated, so the translation covers the apostille too.
Which FDA certificate do I need for a COFEPRIS registration?
Usually a CFG or Certificate of Free Sale for medical devices and foods, a CPP for medicines, 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.
Can you ship the apostilled certificate to Mexico City or Guadalajara?
Yes. We ship by FedEx using our label or your own FedEx account, to you or directly to your registration holder or translator anywhere in Mexico.
How long does an FDA apostille for Mexico 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 Mexico
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 Apostilled for Mexico
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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