Import of Refurbished Medical Devices Halted Pending Regulatory Framework

ENA Sectors 2025-01-17 15:44:05 New Delhi, Jan 17 (KNN) In a move that has sent ripples through the healthcare industry, the Central Drugs Standard Control Organisation (CDSCO) has announced a halt on the import of pre-owned and refurbished medical devices into India until a dedicated regulatory framework is in place. This decision, revealed during a joint workshop with the Confederation of Indian Industry on medical device regulation, underscores growing concerns about patient safety and compliance gaps. Deputy Drugs Controller (India) Aseem Sahu confirmed that consignments of refurbished devices found at ports would be returned, emphasising the absence of regulations under the Medical Devices Rules, 2017, for such imports. A January 10 letter to customs officials clarified that no licenses would be issued for these devices, effectively suspending their sale and distribution in India. The move has caught the industry off guard. Valued at Rs 1,500 crore, the refurbished medical equipment market constitutes 10 per cent of Indias medical equipment industry, serving vital needs in Tier-II to Tier-IV cities and rural areas. Industry experts and stakeholders have expressed concern about the disruption this decision might cause. The Ministry of Health is working to form a high-level expert committee to address these regulatory gaps. The Medical Technology Association of India (MTaI) has warned of potential irreversible damage to healthcare providers and the workforce if a policy framework is not expedited. Rajiv Nath, coordinator for the Association of Indian Medical Device Industry (AiMED), welcomed the suspension, citing patient safety as a priority. He urged alignment with the National Medical Devices Policy, 2023, which aims to position India as a global manufacturing hub. The import of refurbished devices had been allowed under the Ministry of Environments 2023 amendment to hazardous waste rules, but patient safety concerns have prompted a re-evaluation. As the industry awaits clarity, stakeholders are urging the government to balance safety concerns with the pressing needs of Indias growing healthcare infrastructure. (KNN Bureau) 40689 https://knnindia.co.in/news/newsdetails/sectors/import-of-refurbished-medical-devices-halted-pending-regulatory-framework 2025-01-17 15:44:05 knnindia.co.in Import of Refurbished Medical Devices Halted Pending Regulatory Framework