Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Apostille for Nicaragua
FDA Apostille for Nicaragua
Nicaragua has applied the Hague Apostille Convention since 14 May 2013. An FDA export certificate for a sanitary registration in Managua needs one U.S. Department of State apostille. You don't need Nicaraguan consulate legalization. Upload the digital certificate and we return it apostilled by FedEx.
- Hague membersince 14 May 2013
- 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 Nicaragua Asks for an Apostilled FDA Certificate
Health products in Nicaragua are regulated by the Ministry of Health (MINSA). Medicines fall under Law No. 292 on Medicines and Pharmacies, which requires sanitary registration before a product can be imported or sold, and MINSA also authorizes imports of regulated products. Registration files for imported products rely on documents from the country of origin, and for U.S. products that means FDA certificates.
Like its Central American neighbours, Nicaragua registers many products under the shared Central American Technical Regulations (RTCA), and it takes part in the regional SIRRS system for recognizing registrations granted elsewhere in the region. The FDA is a federal agency, so only the U.S. Department of State can apostille its certificates. We handle that and ship the result to you or your Nicaraguan representative.
Which FDA Certificate Does Your Nicaraguan Importer Need?
Match your product to the Nicaraguan authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Nicaraguan authority | FDA certificate |
|---|---|---|
| Medicines | Ministry of Health (MINSA), under Law No. 292 on Medicines and Pharmacies | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | Ministry of Health (MINSA) | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food, ingredients & infant formula | MINSA food registration, under RTCA | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements & medical foods | MINSA, depending on how the product is classified | Certificate of Free Sale (CFS) |
| Cosmetics & hygiene products | MINSA, under RTCA | Certificate for Cosmetics |
MINSA handles sanitary registration and import authorizations across these product groups, with agricultural products overseen separately. Your Nicaraguan representative will confirm the current requirements and the FDA certificate MINSA expects.
How the FDA Apostille for Nicaragua Works
The Hague Apostille Convention has been in force for Nicaragua since 14 May 2013, 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 Nicaragua 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 Managua or anywhere else.
Exporting to Nicaragua: What to Prepare
Registration and import authorization
In Nicaragua, a product generally needs both a sanitary registration and MINSA authorization for each import. Keep your apostilled FDA certificate on file with your importer, as it supports both steps.
Regional recognition is for regional products
Nicaragua takes part in SIRRS, the Central American system for mutual recognition of sanitary registrations. It is designed for products made in Central America, so a U.S.-made product normally needs its own Nicaraguan registration, supported by its own apostilled FDA certificate.
Spanish and a local representative
Files are prepared in Spanish through a Nicaraguan representative or distributor. Translate the FDA certificate after the apostille is attached, and make sure the company names on it match the representative's records.
Screen your trading partners
The U.S. maintains targeted sanctions on certain Nicaraguan individuals and entities. Screen your distributor and other parties against U.S. sanctions lists before you ship. Our service covers only the apostille of your FDA certificate.
FDA Apostille Cost for Nicaragua
| 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 Nicaragua: FAQs
Is Nicaragua a member of the Hague Apostille Convention?
Yes. Nicaragua joined by accession, and the Convention has applied there since 14 May 2013. A U.S. Department of State apostille is enough, so no Nicaraguan consulate legalization is required.
Who registers health products in Nicaragua?
The Ministry of Health (MINSA). Medicines are regulated under Law No. 292 on Medicines and Pharmacies, and MINSA also authorizes imports of regulated products.
Can a registration in another Central American country help in Nicaragua?
Generally only for products made in Central America. The regional SIRRS mutual-recognition system doesn't cover U.S.-made products, which normally need their own Nicaraguan registration.
Does my FDA certificate need a Spanish translation?
Usually yes. Nicaraguan files are prepared in Spanish. Translate after the apostille is attached so both are covered.
Which FDA certificate do I need for Nicaragua?
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 Nicaragua 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 Nicaragua
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 Nicaragua
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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