• The Central Drugs Standard Control Organisation (CDSCO) has prohibited importing pre-owned and refurbished medical devices until specific regulations are formulated.
  • Valued at ₹1,500 crore, the pre-owned medical equipment market plays a vital role in India's healthcare, especially in rural and smaller cities.
  • The decision follows concerns raised by lobby groups over unregulated imports of second-hand medical devices like CT scanners and MRI machines.

The Central Drugs Standard Control Organisation (CDSCO) has banned the import of pre-owned and refurbished medical devices until specific regulations are established. At a workshop on medical device regulation with the Confederation of Indian Industry, Deputy Drugs Controller (India) Aseem Sahu stated that shipments of such devices at ports would be returned.

This follows a January 10 CDSCO letter clarifying that refurbished devices cannot be imported for sale or distribution due to the lack of provisions under the Medical Devices Rules, 2017. Health ministry officials stated that a high-level expert committee is being formed to discuss regulatory aspects with stakeholders regarding the import of refurbished medical devices. 

Some experts expressed surprise at the sudden decision, citing a lack of prior notice from the ministry.

Valued at ₹1,500 crore, the pre-owned medical equipment market accounts for 10% of India’s medical equipment industry, addressing growing demand in Tier-II, Tier-III, Tier-IV cities, and rural areas.

The Medical Technology Association of India (MTaI) has emphasized the urgent need for a quick policy framework, warning that delays could cause irreversible harm to healthcare providers and the workforce.

The decision to restrict imports comes after lobby groups urged the health ministry to withdraw policies allowing unregulated imports of second-hand medical equipment, including CT scanners and MRI machines, citing patient safety risks.

Rajiv Nath, coordinator of the Association of Indian Medical Device Industry (AiMED), supported the move, noting that while some ministries permit such imports under e-waste regulations, the CDSCO must address critical patient safety concerns linked to these high-risk devices.

Edited by Harshajit Sarmah