Medical Devices Rules, 2017

The Ministry of Health and Family Welfare has constituted a committee to frame a policy for refurbished medical devices amid disputes between domestic and global manufacturers. The move addresses regulatory ambiguity concerning used and refurbished equipment.

Refurbished Medical Devices – Regulatory Framework

Dimension	Key Details
Definition	Pre-used medical equipment restored to original operating specifications and resold at lower cost
Capital Nature	Comprises capital-intensive technologies
Equipment Covered	Includes MRI, CT scanners, PET-CT systems, robotic surgery systems, endoscopy and laparoscopy equipment
Cost Comparison	MRI 1.5T new 4 to 8 crore refurbished 1 to 3.5 crore; PET-CT new 20 plus crore refurbished 0.6 to 3.5 crore; CT scanner new 2 to 4 crore refurbished 0.2 to 2.5 crore
Medical Devices Rules 2017	Provides no dedicated regulatory pathway for refurbished medical devices
Drugs and Cosmetics Act 2020	Notifies all medical devices as drugs but does not separately define refurbished products
Import Regulation Authorities	Imports require No Objection Certificates under Ministry of Environment Forest and Climate Change; quality assurance provided by CDSCO; import authorisation governed by DGFT
Hazardous and Other Wastes Rules 2016	Governs import of used medical equipment
Regulatory Status	No legal definitions exist for used refurbished reconditioned or remanufactured medical devices