 "CDSCO to disallow import of pre-owned, refurbished med devices into India")
The import of pre-owned and refurbished, or second-hand, medical devices into India will not be allowed by the Central Drugs Standard Control Organisation (CDSCO) until a regulation is established for such devices, according to senior officials.
In a joint workshop between CDSCO and the Confederation of Indian Industry on medical device regulation held on Wednesday, Deputy Drugs Controller (India) Aseem Sahu announced that any consignment containing refurbished devices present at ports would not be released and would have to be returned.
This comes after CDSCO, in a letter to the Principal Commissioner of Customs dated January 10, clarified that refurbished medical devices cannot be imported into the country for sale and distribution, as there is no specific regulation for such devices under the Medical Devices Rules, 2017.
The letter, reviewed by Business Standard, adds that no licence is issued for the import of such devices.
Officials also said that the Ministry of Health is working to constitute a high-level expert committee to discuss regulatory aspects with stakeholders regarding the import of refurbished medical devices.
Industry experts say the import of such devices may remain suspended until a regulation is passed by the expert committee. One expert mentioned that the industry was shocked by the lack of prior notice from the health ministry.
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Valued at Rs 1,500 crore, the pre-owned medical equipment market currently constitutes around 10 per cent of the total medical equipment industry in India, playing a critical role in meeting the growing demand in Tier-II, -III, and -IV cities, as well as rural and underserved areas.
Highlighting the need for a fast policy framework, the Medical Technology Association of India (MTaI) said that if a swiftly implementable policy is not introduced soon, it could lead to irreversible damage to both healthcare providers and the workforce.
The move to disallow imports also follows several lobby groups urging the health ministry to intervene and recall the policy that allows the unregulated influx of second-hand medical equipment such as computed tomography scanners and magnetic resonance imaging machines, citing patient safety concerns.
Welcoming the step, Rajiv Nath, forum coordinator for the Association of Indian Medical Device Industry (AiMED), said that while one ministry and its regulations may permit the import of pre-owned medical devices with respect to e-waste management concerns, other regulators like CDSCO must play their part in addressing the high-risk patient safety concerns.
“We hope that the policy review underway at the health ministry will consider alignment with the National Medical Devices Policy, 2023, which envisions India emerging as the leading manufacturing hub for medical devices,” he added.
The import of refurbished medical devices was allowed into India after the enactment of the Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules by the Ministry of Environment, Forest and Climate Change (MoEFCC) in 2023.
The original list, passed by the Directorate General of Health Services (DGHS), included 50 pre-owned high-end and high-value devices that could be imported based on the needs and requirements of user hospitals. This list was later reduced to 38 devices in October 2024.
The rules also allowed equipment that had been used for up to five years from the date of manufacture to be imported for reuse.
“To safeguard the interests of the healthcare system and the refurbished medical device sector, it is imperative that the expert committee expedites the creation of this policy. Meanwhile, to avoid disruptions, imports should be allowed through necessary approvals by DGHS and MoEFCC,” MTaI added.