New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has announced that the import of second-hand or refurbished medical devices is not permitted. In a recent communication to the principal commissioner of Customs, the regulator instructed the Customs department to stop releasing such devices at ports of entry.

The letter, a copy of which is with The Times of India, highlighted that the Medical Devices Rule, 2017, does not include provisions for regulating refurbished medical devices.

According to the Association of Indian Medical Device Industry (AiMeD), an estimated 60% of the ₹40,000 crore worth of imported medical electronic equipment consists of pre-owned devices. “This policy intervention is a significant step in protecting the domestic industry from the dumping of equipment with uncertain quality. It will also ensure patients receive appropriate medical care,” said Dr. Jitendra Sharma, Managing Director of AMTZ, Visakhapatnam.

Dr. Aakaar Kapoor, founder-partner of City Imaging & Clinical Labs, raised safety concerns, noting that refurbished machines may have issues like higher radiation emissions, which could harm patients. “Newer imaging systems emit significantly lower radiation, addressing exposure concerns during scans,” Kapoor explained.

While med-tech companies have welcomed the move, viewing it as a boost for local manufacturing and the adoption of advanced equipment, hospitals and diagnostic centers have expressed apprehension. They argue the policy may drive up costs.

“The lower cost of imaging tests in India compared to developed nations is partly due to the use of refurbished machines. Instead of an outright ban, the government should introduce regulations to ensure the devices meet updated standards,” suggested the owner of a Delhi-based hospital.