USTR Flags Barriers to US Medical Device Exports to India
Ahead of the April 2 tariff rollout, the US Trade Representative (USTR) has raised concerns about barriers to US medical device exports to India in its 2025 National Trade Estimate (NTE) Report.
Key Issues:
High tariffs: India raised tariffs on 70 product categories, including medical devices and chemicals, without notice in its 2019–20 Budget.
Price caps: Government-set price limits on coronary stents and knee implants haven’t adjusted for inflation, discouraging US companies.
Import restrictions: Lack of clear guidelines for refurbished medical device imports has led to delays. Since April 2024, approvals have been suspended, affecting MRI scanners and robotic-assisted surgery systems.
Strict customs rules: Extensive paperwork and inspections slow down the import process.
Quality control challenges: India’s Bureau of Indian Standards (BIS) imposes strict, non-aligned global standards, creating compliance difficulties.
The USTR report warns that these barriers hurt US businesses and restrict access to India’s medical device market.
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