Refurbished Medical Devices

Why in News?

Recently, the Ministry of Health and Family Welfare has formed a committee to frame a policy for refurbished medical devices amid a dispute between domestic and global manufacturers.

• Refurbished medical devices – They are pre-used equipment restored to original operating specifications and resold at a lower cost.
  • They are capital-intensive technologies.
• Components – Includes high-end systems like MRI, CT scanners, PET-CT systems, robotic surgery systems, endoscopy and laparoscopy equipment.
• Procurement Cost –

• Lower cost helps hospitals in Tier-2, Tier-3 cities and standalone diagnostic centres.
• Regulatory Framework – Medical Devices Rules, 2017 – No dedicated regulatory pathway for refurbished medical devices.
• Drugs and Cosmetics Act, 2020 – Under which all medical devices are notified as “drugs”, but refurbished products are not separately defined.
• Import Regulations – Imports allowed through No-Objection Certificates (NOCs) issued by an expert committee under the Ministry of Environment, Forest and Climate Change (MoEFCC).
  • Central Drugs Standard Control Organisation (CDSCO) –Provides quality assurance and other reports.
  • Directorate General of Foreign Trade (DGFT) – Import authorisation.
• Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 – Primarily governs Imports of used medical equipment.

• Status – India has no legal definitions for “used”, “refurbished”, “reconditioned”, or “remanufactured” medical devices, causing regulatory ambiguity.
• Expert concern – Risk India becoming a dumping ground for outdated technology.

Reference

IE | Refurbished Medical Devices