Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Apostille for Guatemala
FDA Apostille for Guatemala
Guatemala has accepted apostilles since 18 September 2017. Before that, U.S. exporters had to go through Guatemalan consular legalization. Now your FDA export certificate needs only a U.S. Department of State apostille to support a sanitary registration with MSPAS. Upload the digital certificate and we return it apostilled by FedEx.
- Hague membersince 18 September 2017
- 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 Guatemala Asks for an Apostilled FDA Certificate
Medicines and related products in Guatemala are registered by the Ministry of Public Health and Social Assistance (MSPAS), through its Department of Regulation and Control of Pharmaceutical and Related Products (DRCPFA). Registrations follow the Central American Technical Regulations (RTCA), and certificates are valid for five years. Registration files for imported products rely on documents from the country of origin, such as a Pharmaceutical Product Certificate and GMP evidence. For U.S. products, the FDA issues those.
Guatemalan registrations have a reputation for long timelines, so getting the documents right the first time matters. The FDA is a federal agency, so only the U.S. Department of State can apostille its certificates. We handle that and ship the apostilled certificate to you or straight to your Guatemalan regulatory agent.
Which FDA Certificate Does Your Guatemalan Importer Need?
Match your product to the Guatemalan authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Guatemalan authority | FDA certificate |
|---|---|---|
| Medicines | MSPAS, Department of Regulation and Control of Pharmaceutical and Related Products (DRCPFA) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | MSPAS, DRCPFA | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food, ingredients & infant formula | MSPAS food control authorities, under RTCA | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements & medical foods | MSPAS, depending on how the product is classified | Certificate of Free Sale (CFS) |
| Cosmetics & hygiene products | MSPAS, DRCPFA, under RTCA | Certificate for Cosmetics |
MSPAS registers these products under Central American Technical Regulations, and procedures are being digitalized. Your Guatemalan regulatory agent will confirm the current requirements and which FDA certificate MSPAS expects.
How the FDA Apostille for Guatemala Works
The Hague Apostille Convention has been in force for Guatemala since 18 September 2017, 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 Guatemala 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 Guatemala City or anywhere else.
Exporting to Guatemala: What to Prepare
Budget for long timelines
U.S. government reporting from 2025 notes persistent delays in Guatemalan registrations and renewals, and dossier changes linked to product or label updates can be treated as new submissions. Have your apostilled FDA certificate ready early, and use our expedited service if a filing window is short.
Regional recognition is for regional products
Guatemala offers homologation under the Central American framework, and the regional SIRRS system lets a registration in one Central American country be recognized in others. That mutual recognition is designed for products made in Central America, so a U.S.-made product normally needs its own Guatemalan registration with its own apostilled documents.
Spanish and a local agent
Files are submitted in Spanish through a registered local agent or distributor, and some steps still require hard-copy documents in Guatemala City. Translate the FDA certificate after the apostille is attached, and send the originals straight to your agent.
Five-year renewals
Sanitary registrations are valid for five years, and renewals are affected by the same backlogs as new files. Start renewals well ahead of the expiry date with a fresh apostilled certificate in hand.
FDA Apostille Cost for Guatemala
| 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 Guatemala: FAQs
Is Guatemala a member of the Hague Apostille Convention?
Yes. Guatemala joined by accession, and the Convention has applied there since 18 September 2017. A U.S. Department of State apostille is enough, so no Guatemalan consulate legalization is required.
Who registers medicines and related products in Guatemala?
The Ministry of Public Health and Social Assistance (MSPAS), through its Department of Regulation and Control of Pharmaceutical and Related Products (DRCPFA), following Central American Technical Regulations (RTCA).
Why do Guatemalan registrations take so long?
U.S. government reporting in 2025 pointed to backlogs, limited access to evaluators and the treatment of some updates as new submissions. Complete, correctly apostilled documents help avoid extra delays.
Can a registration in another Central American country help?
Generally only for products made in Central America. The regional mutual-recognition system doesn't cover U.S.-made products, which normally need their own Guatemalan registration. Ask your agent about homologation options for your product.
Which FDA certificate do I need for Guatemala?
A CPP for medicines, a CFG for medical devices and conventional foods, a Certificate of Free Sale for supplements, and a Certificate for Cosmetics for cosmetic and hygiene products. Products not sold in the U.S. need a Certificate of Exportability.
How long does an FDA apostille for Guatemala 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 Guatemala
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 Guatemala
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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