India’s refurbished medical device market is valued at ₹1,500 crore, about 10% of the sector, helping small hospitals cut costs but raising safety concerns
The current Medical Devices Rules, 2017, make no distinction between new and refurbished machines, creating regulatory blind spots
Other regions offer lessons: Europe enforces the same strict standards for refurbished and new devices, while the US distinguishes servicing from remanufacturing
India could allow imports only from original makers or certified partners, bar overused machines, and mandate safety tests, IDs, warranties, and public registries
A refurbishment ecosystem within India can cut costs, create jobs, and boost transparency. The challenge is training skilled technicians for testing and calibration
This debate is not old versus new machines. A balanced framework can expand affordable care while ensuring safety, anchoring a stronger healthcare system