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India bans the import of used medical devices

May 1, 2025
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Why this is important to Wisconsin businesses: Wisconsin companies may be able to fill gaps in the need for new, state-of-the-art equipment by partnering with Indian businesses.

India’s government has banned the import of used and refurbished medical devices and equipment for sale and distribution.

The regulation, issued Jan. 10, 2025, is expected to last until a new policy is enacted. No timeframe has been released on that yet, as the Ministry of Health is forming a committee to develop new rules.

According to the U.S. Department of Commerce’s International Trade Administration (ITA), the need for medical devices is growing rapidly in India with an expanding middle class, an aging population, and rising prevalence of chronic diseases. The market is projected to jump from $12 billion in 2023-24 to $50 billion by 2030, an ITA report said.

Up to now, India has relied on imports for nearly 70% of its medical devices, the ITA said. In fact, U.S. medical device exports to India rose by 66% in the 2024 fiscal year, reaching $1.45 billion—up from $872 million in fiscal 2020.

According to the Association of Indian Medical Device Industry, nearly 60% of the medical electronic devices imported into the country are pre-owned equipment, the Times of India reported.

Medical device manufacturers in India applauded the new rule, saying it will help their domestic industry and will ensure the safety of patients, as older machines—even refurbished ones—often emit more radiation than newer versions. However, hospital officials cautioned that new machines are more expensive than older equipment and that will increase the cost of care.

Until the directive was issued, the Directorate General of Health Services had approved the limited import of 50 previously owned high-end devices—a list that was later narrowed to 38 items, including imaging systems with a residual life of at least seven years and no more than five years of prior use.

While the ban restricts refurbished imports, it may create opportunities for Wisconsin companies that make new medical equipment and components. The ITA said U.S. companies can also tap into the rising demand for telemedicine, remote monitoring, and other digital health solutions.

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