Refurbished medical devices: a new global vs domestic debate, Pg9

Key Highlights:

• The import of refurbished medical devices has sparked debate in India, dividing domestic manufacturers and international associations.
• The Ministry of Health and Family Welfare (MoHFW) has formed a committee to assess the safety and regulation of refurbished devices.
• India currently lacks a dedicated regulatory pathway for refurbished medical devices under the Medical Devices Rules, 2017.
• The refurbished medical device segment in India is estimated to be around Rs 1,500 crore, approximately 10% of the total market.
• Amendments in December 2022 permitted the import of certain high-end and high-value used medical equipment under specific conditions.

Detailed Insights:

• Refurbished medical equipment refers to used devices restored to their original specifications and sold at a lower cost, including high-value systems like CT scanners and MRI machines.
• India relies on imports from countries like the US, Germany, Japan, and the Netherlands for advanced imaging technologies, including refurbished equipment.
• Imports of used medical equipment are governed by the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016, with amendments made in December 2022 to allow certain high-end equipment.
• A committee under the Ministry of Environment, Forest and Climate Change (MoEFCC) cleared several high-end refurbished devices in November 2025 under waste management rules, creating conflict with the CDSCO's stance.
• The Medical Technology Association of India (MTAI) advocates for a clear policy instead of a ban, while the Association of Indian Medical Device Industry (AiMeD) opposes relaxed restrictions without a robust regulatory framework.
• Concerns exist that importing older, refurbished equipment at prices similar to new domestic products could discourage investment in indigenous manufacturing of high-end technologies.

Key Concepts Involved:

• Refurbished Medical Devices: Used medical devices restored to original operating specifications and sold at a reduced price.
• Medical Devices Rules, 2017: The regulatory framework in India governing the manufacturing, import, and sale of medical devices.
• CDSCO (Central Drugs Standard Control Organisation): The national regulatory body for pharmaceuticals and medical devices in India.