US Medical Equipment Suppliers: A Buyer’s Guide
To import medical devices from the United States you almost always need two things: an FDA document that shows their regulatory status in the U.S., and the health registration of your own country. This guide explains how they fit together.
| Industry | Medical equipment |
|---|---|
| Main tariff headings (Harmonized System) | 9018, 9019, 9020, 9021, 9022, 9402, 3005 and 3006 |
| U.S. agencies involved | Food and Drug Administration (FDA); U.S. International Trade Commission (USITC) |
| Official sources cited | 5 |
| Last reviewed | 2026-10-07 |
Tariff headings you should know
- 9018: instruments and appliances used in medical, surgical, dental or veterinary sciences.
- 9019: mechano-therapy, massage, oxygen therapy, respiratory therapy and similar apparatus. 9020: other breathing appliances.
- 9021: orthopedic appliances, prostheses and implants.
- 9022: X-ray apparatus and apparatus based on other ionizing radiation.
- 9402: medical, surgical, dental or veterinary furniture.
- 3005 and 3006: dressings, bandages and certain pharmaceutical goods.
FDA export certificates
The FDA issues four types of export certificates for medical devices, depending on their marketing status. The Certificate to Foreign Government (CFG) is issued for devices that are legally marketed in the United States, and it is the one that health authorities at destination usually ask for.
Since January 2024, the FDA issues these certificates in electronic format. The manufacturer or exporter requests them; ask your supplier for it so you can prepare the registration in your country.
Health registration in your country (examples from Latin America)
- Mexico: COFEPRIS grants the health registration and the health import permit for medical devices.
- Colombia: INVIMA, with import approval through the VUCE single window.
- Argentina: ANMAT, through its National Institute of Medical Products.
- Costa Rica: the Ministry of Health registers biomedical equipment and material.
- Bolivia: AGEMED. Honduras: ARSA. Panama: MINSA. Paraguay: DINAVISA. Dominican Republic: DIGEMAPS.
- In any other country, ask the health authority which registration applies before you buy.
How to choose and verify the supplier
- Ask for the FDA CFG before you commit to the purchase.
- If the equipment is used or refurbished, first confirm with your country’s health authority whether it is allowed and under what requirements.
- Ask for manuals and labeling in your language, training and a guarantee of spare parts.
- Check that the company exists: business registration in its state, physical address, website and references from other buyers.
- Check that it does not appear on the U.S. restricted-party lists, and ask for a formal quotation with the Incoterm, lead time and payment terms.
Frequently asked questions
What is the FDA Certificate to Foreign Government (CFG)?
It is an export certificate that the FDA issues for medical devices that are legally marketed in the United States. Many health authorities ask for it to grant registration.
Who handles the health registration in my country?
Normally the importer or a local holder, before the health authority (for example, COFEPRIS, INVIMA or ANMAT). Agree on it with the manufacturer before you buy.
Official sources
- FDA: types of export certificates for medical devices
- USITC: Harmonized Tariff Schedule of the United States
- COFEPRIS (Mexico): imports (in Spanish)
- INVIMA (Colombia): authorizations and licenses in the VUCE (in Spanish)
- ANMAT (Argentina): procedures (in Spanish)
This page is general information to help you get started. It is not legal, tax or customs advice, and regulations change. Confirm current requirements with the official sources above or with a licensed customs broker, freight forwarder or trade compliance professional.