India Bans Refurbished Medical Device Imports to Boost Safety and Innovation

on
January 21, 2025

India’s medical device industry has welcomed the Central Drugs Standard Control Organisation’s (CDSCO) decision to prohibit the import of refurbished medical devices. The regulatory body clarified that such imports are not permitted under the Medical Devices Rules, 2017, citing the absence of certification protocols to ensure patient safety.

This move is seen as a step toward strengthening the vision of Aatmanirbhar Bharat by supporting indigenous manufacturers and preventing India from becoming a dumping ground for outdated and unsafe medical equipment. Industry experts have long raised concerns over uncertified devices jeopardizing patient care, particularly in Tier-II and rural healthcare settings.

Vishwaprasad Alva, founder of Skanray Technologies, applauded the decision, stating: “Used medical equipment import was an error that the government has now corrected. The government seems serious about world-class healthcare and fostering homegrown manufacturing.”

While the pre-owned medical equipment market, valued at ₹1,500 crore, has played a crucial role in underserved regions, the lack of regulation made it a potential risk for healthcare safety. The Ministry of Health is now constituting an expert committee to evaluate regulatory frameworks for these imports, which remain suspended until further notice.

This ban underscores the government’s commitment to ensuring patient safety, reducing e-waste, and fostering domestic research and development.