The short answer
Costa Rica is one of Latin America’s biggest medical device manufacturing hubs and a top supplier of pineapples, bananas and coffee to the U.S. Device plants and food exporters follow very different FDA rules.
What Costa Rican exporters should watch for
🩺 Medical device plants
Contract manufacturers and device plants that make devices for the U.S. must register with FDA every year, list the devices they make, name a U.S. Agent and pay FDA’s annual fee. Since February 2, 2026, FDA’s device quality rule is the QMSR, which incorporates ISO 13485.
🍍 Pineapples and bananas
Fresh fruit needs USDA APHIS entry approval. On the FDA side, farms meet the Produce Safety Rule and packing houses that are not part of a farm register with FDA.
☕ Coffee
Processing plants and warehouses register with FDA and name a U.S. Agent; each shipment needs Prior Notice.
🧃 Juice and processed fruit
Juice and fruit concentrate processors must follow juice HACCP; canned or acidified products need FCE/SID filings.
Common reasons Costa Rican shipments are stopped
- Device plants not registered or devices not listed
- Quality system findings at FDA inspections
- Pesticide residues on fruit
- Juice HACCP not in place
- Labeling — Spanish-only labels
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP importer service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
What you need to register — and what it costs
| Product type | FDA requirement | Orionex price |
|---|---|---|
| Food, beverages, supplements | Food facility registration + U.S. Agent, renewed every 2 years; Prior Notice for each shipment | $300/year or $450 for 2 years |
| Cosmetics | MoCRA facility registration (every 2 years) + product listing + U.S. Agent | $300/year or $450 for 2 years; listing $150/product |
| Medical devices | Establishment registration (yearly, FDA fee paid separately) + device listing; 510(k) for many Class II devices | $550/year; listing $50/device |
| Drugs (incl. OTC) | Drug establishment registration (yearly) + NDC labeler code + drug listing | $550/year; listing $350/product |
Every Orionex registration includes the U.S. Agent service, D-U-N-S number set-up where needed and a Certificate of Registration. All prices →
Tell us your products — we’ll confirm what you need to register, in writing, by email.
Frequently asked questions
Do Costa Rican contract manufacturers need FDA registration?
Yes. A contract manufacturer that makes finished devices or components sold as devices for the U.S. market must register its establishment with FDA, list the devices it makes, name a U.S. Agent and pay the annual establishment fee. FDA can inspect the plant under the QMSR.
Do Costa Rican pineapple exporters need FDA registration?
Farms are generally exempt but must meet the Produce Safety Rule. Packing houses that are not part of a farm must register with FDA and name a U.S. Agent, and USDA APHIS rules apply to fresh fruit.
Sources
- FDA — Quality Management System Regulation (QMSR)
- FDA — FSMA Final Rule on Produce Safety
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.