India to USA · sector guide
Exporting medical devices from India to the USA
The US imported $497M of medical devices from India in 2025, 0.7% of its imports of the main products in this sector. Surgical instruments, syringes, diagnostic equipment, orthopaedic devices and supplies.
- US imports from India, 2025
- $497M
- Jan–Aug 2026 vs last year
- -23%
- India's share
- 0.7%
- Average duty paid
- 14.8%
- Shipped by sea
- 27%
Five-year trend
US imports of medical devices from India
Jan–Aug 2026: $263M, down 23% on the same months last year.
Top products
What the US buys most
| Product | HS | 2025 |
|---|---|---|
| Medical & Surgical Instruments | 9018 | $327M |
| X-Ray Equipment | 9022 | $127M |
| Orthopaedic Appliances | 9021 | $36.7M |
US ports
Where it enters the US
| US port | Share |
|---|---|
| Chicago, IL | 13.8% |
| New Orleans, LA | 13.1% |
| Newark, NJ | 7.8% |
| JFK International Airport, NY | 7% |
| Savannah, GA | 6.5% |
| Cleveland, OH | 6.4% |
Requirements
US rules for medical devices
- FDADevice makers must register their establishment and list their devices with the FDA; many devices also need 510(k) clearance before sale.
- CBPAn Importer Security Filing must reach CBP at least 24 hours before the container is loaded in India.
- CBPGoods and their retail packaging must show the country of origin in English, for example "Made in India".
On the Indian side
- Register with the export promotion council for your product, and keep the FDA registration and listing numbers ready for the buyer's entry.
Packing and shipping
- Higher-value devices often go by air; bulk consumables such as syringes and gloves ship by sea.
Questions
Medical Devices from India to the USA: FAQs
How much medical devices does the US import from India?
$497M in 2025, led by medical & surgical instruments, x-ray equipment, orthopaedic appliances. Jan–Aug 2026: $263M, down 23% on the same months last year.
What US rules apply to medical devices from India?
FDA: Device makers must register their establishment and list their devices with the FDA; many devices also need 510(k) clearance before sale. CBP: An Importer Security Filing must reach CBP at least 24 hours before the container is loaded in India. CBP: Goods and their retail packaging must show the country of origin in English, for example "Made in India".
What do Indian exporters of medical devices need to do?
Register with the export promotion council for your product, and keep the FDA registration and listing numbers ready for the buyer's entry.
Source: U.S. Census Bureau international trade data (general imports, and duty calculated on imports for consumption), 2021–2025 and Jan–Aug 2026. Requirements summarised for guidance; check the agency rules for your exact product.
Exporting medical devices to the USA?
Atmavaan books the container, handles the export paperwork and can file the ISF and clear US customs for your buyer.
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