Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Apostille for Dominican Republic
FDA Apostille for the Dominican Republic
The Dominican Republic has accepted apostilles since 30 August 2009. To use your FDA export certificate for a DIGEMAPS sanitary registration in Santo Domingo, it needs a single apostille from the U.S. Department of State, with no Dominican consulate legalization. Upload the digital certificate and we ship it back apostilled by FedEx.
- Hague membersince 30 August 2009
- 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 the Dominican Republic Asks for an Apostilled FDA Certificate
Medicines, food, beverages, cosmetics and other health products imported into the Dominican Republic need a sanitary registration (registro sanitario) from DIGEMAPS, the health-products directorate of the Ministry of Public Health. Registration files for U.S. products typically include an FDA certificate showing the product is legally sold in the United States, and the authority expects that certificate to carry an apostille.
U.S. exporters have strong ties to this market through the CAFTA-DR trade agreement, and Dominican distributors are used to requesting apostilled FDA paperwork. The FDA is a federal agency, so its certificates can only be apostilled by the U.S. Department of State. We take care of that step and send the finished document to you or straight to your Dominican importer or registration agent.
FDA certificates we apostille for the Dominican Republic
Which FDA Certificate Does Your Dominican Importer Need?
Match your product to the Dominican authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Dominican authority | FDA certificate |
|---|---|---|
| Medicines | DIGEMAPS, Ministry of Public Health (MISPAS) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices & sanitary products | DIGEMAPS, Ministry of Public Health (MISPAS) | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food, beverages & infant formula | DIGEMAPS, Ministry of Public Health (MISPAS) | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements & medical foods | DIGEMAPS, Ministry of Public Health (MISPAS) | Certificate of Free Sale (CFS) |
| Cosmetics & personal hygiene | DIGEMAPS, Ministry of Public Health (MISPAS) | Certificate for Cosmetics |
DIGEMAPS (Dirección General de Medicamentos, Alimentos y Productos Sanitarios) reviews all of these product groups. Its document requirements are set by resolutions that change over time, so confirm the current checklist with your Dominican registration agent before you request the FDA certificate.
How the FDA Apostille for the Dominican Republic Works
The Hague Apostille Convention has been in force for the Dominican Republic since 30 August 2009, 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 the Dominican Republic 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 Santo Domingo or anywhere else.
Exporting to the Dominican Republic: What to Prepare
One authority, one registration per product
DIGEMAPS handles medicines, food, cosmetics and sanitary products, and each product needs its own registro sanitario. If you're registering several products at once, check whether one FDA certificate can list them all, or whether DIGEMAPS wants a separate certificate for each.
Plan for a Spanish translation
Spanish is the official language, and Dominican authorities generally expect foreign documents in Spanish. Your agent will usually arrange an official translation. Have it done after the apostille is attached so the apostille is translated too.
A local holder is needed
Sanitary registrations are normally filed and held by a company or representative in the Dominican Republic. Agree early who will hold the registration, and make sure the company names on the FDA certificate match your agreement with them.
Watch certificate dates
Registration files are often reviewed against the date the supporting certificate was issued. Apostille the FDA certificate soon after you receive it, and use expedited processing if a filing deadline is close.
FDA Apostille Cost for the Dominican Republic
| 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 the Dominican Republic: FAQs
Is the Dominican Republic a member of the Hague Apostille Convention?
Yes. The Convention has applied in the Dominican Republic since 30 August 2009, so a U.S. Department of State apostille is enough. You don't need legalization at the Dominican Embassy or a consulate.
What is DIGEMAPS and why does it want an apostilled FDA certificate?
DIGEMAPS is the directorate of the Dominican Ministry of Public Health that issues sanitary registrations for medicines, food, cosmetics and other health products. It uses the FDA certificate as proof that your product is legally sold in the U.S., and the apostille proves the certificate is genuine.
Does the certificate need to be translated into Spanish?
Usually yes. Dominican authorities generally expect documents in Spanish, and your registration agent will typically arrange an official translation. Translate the certificate after the apostille is attached so both are covered.
Which FDA certificate should I get for a Dominican sanitary registration?
Use 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 and personal-care products. Confirm the exact type with your agent before you apply to the FDA.
Can you send the apostilled certificate straight to Santo Domingo?
Yes. We ship by FedEx using our label or your own FedEx account, to you or directly to your importer or registration agent in the Dominican Republic.
How long does an FDA apostille for the Dominican Republic 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 when a registration deadline is close.
FDA Certificates We Apostille for the Dominican Republic
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 the Dominican Republic
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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