Archive · 12 Dec 2025
India Approves Refurbished Medical Device Imports Amid Safety Concerns
A panel under India's environment ministry has approved the import of refurbished medical equipment like CT scanners, MRI systems, and surgical robots.
This decision has sparked controversy because India's top health regulator, the CDSCO, has banned such imports due to lack of regulations.
Domestic medical device makers are worried that this will make India a dumping ground for old equipment and hurt their business.
They argue that using refurbished equipment is unsafe and unfair.
A company that got approval, Intuitive Surgical India, says their refurbished systems are safe and help provide advanced medical care.
The issue is now in court, with a consumer rights group asking for stricter rules on these imports.
A Union environment ministry panel approved the import of 16 CT scanners, 10 MRI systems, and 10 surgical robotic units on November 12.
The CDSCO has banned the import of refurbished medical devices due to lack of regulatory provisions.
Domestic medical device makers argue that importing refurbished equipment is unsafe and unfair, making it hard for them to compete.
Intuitive Surgical India, one of the companies approved for imports, defends the practice, stating their refurbished systems meet the same safety standards as new devices.
The dispute has escalated to the Delhi High Court, with a consumer rights group petitioning for stricter oversight of refurbished medical equipment imports.
- Who
- Union environment ministry panel, domestic medical device makers, Intuitive Surgical India
- What
- Approval for the import of refurbished medical equipment
- When
- November 12, 2023
- Where
- India
- Why
- To allow refurbished systems when new options are unavailable or unaffordable, according to 2023 rules
- Date of Approval
- November 12
- Number of CT Scanners Approved
- 16
- Number of MRI Systems Approved
- 10
- Number of Surgical Robotic Units Approved
- 10
- Date of CDSCO Clarification
- January 10
- Number of Eligible Categories for Refurbished Equipment
- 38
- Company Defending Imports
- Intuitive Surgical India
- Court Involved
- Delhi High Court