The Government of India has started consultations to frame new regulations for refurbished medical device imports. A high-level inter-departmental committee is currently reviewing data and seeking inputs from the Ministry of Health and Family Welfare (MoHFW), Directorate General of Health Services (DGHS), Central Drugs Standard Control Organisation (CDSCO), the Department of Pharmaceuticals, and key industry stakeholders.
At present, the Medical Devices Rules (MDR), 2017 do not specifically cover refurbished medical devices. Imports are being managed through no-objection certificates (NOCs) issued by the Ministry of Environment, Forest and Climate Change (MoEFCC) for select high-end equipment.
Currently, India allows imports of pre-owned equipment such as robotic-assisted surgical systems, linear accelerators (LINACs), and CT scanners under strict conditions. These include:
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- Devices must not be phased out in the exporting country.
- Equipment must be free of hazardous materials.
- A minimum of seven years of residual life must remain.
However, the absence of clear regulations has raised concerns about patient safety, quality standards, and unregulated inflow of second-hand devices. Domestic manufacturers have called for restrictions to protect local industry, while hospital groups argue that refurbished devices ensure affordable access to advanced technology in tier-II cities and rural markets.
The government is now working on a draft framework that may introduce minimum service life requirements, approved equipment categories, and compliance procedures. Until the new policy is finalized, refurbished medical device imports will remain restricted and closely monitored. A draft policy for public consultation is expected soon.
Need Guidance on Refurbished Medical Device Imports?
How Operon Strategist Can Help
As India moves toward drafting clear regulations for refurbished medical device imports, manufacturers, hospitals, and distributors will need expert guidance to stay compliant. Operon Strategist can support you with:
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Regulatory Consulting – Assistance in understanding and aligning with evolving CDSCO and MoHFW requirements.
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Import Licensing & Documentation – End-to-end support for preparing and filing the necessary applications, including no-objection certificates and import approvals.
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Quality & Compliance – Guidance on meeting safety, performance, and residual life standards as required for refurbished equipment.
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Strategic Advisory – Helping hospitals, startups, and distributors navigate policy changes and build long-term strategies for cost-effective medical device access.
With experience in medical device regulations and turnkey project consulting, Operon Strategist ensures you are prepared for both current compliance and upcoming policy shifts.
Contact us today to discuss your compliance needs and ensure a smooth entry of refurbished medical devices into the Indian market.
