Government Considers Specific Regulatory Rules for Refurbished Medical Device Imports

An interministerial committee set up by the central government is currently examining the policy framework for importing refurbished medical devices, as discussions continue over safety standards, age limits, and eligible product categories. The discussions directly affect India’s pre-owned medical equipment market, which industry executives value at approximately ₹1,500 crore, representing nearly 10 per cent of the country’s total medical equipment sector.

What Happened

The government formed an interministerial committee to formulate guidelines governing the import of second-hand and refurbished healthcare machinery. The panel includes representatives from the Ministry of Health and Family Welfare (MoHFW), the Directorate General of Health Services (DGHS), the Central Drugs Standard Control Organisation (CDSCO), the Department of Pharmaceuticals, and industry stakeholders. According to people familiar with the matter, the panel has held preliminary meetings and started assessing data from the refurbished device sector.

Currently, the Medical Devices Rules (MDR), 2017 do not make a legal distinction between brand-new and refurbished equipment, an issue confirmed by the CDSCO in a January 10, 2025 communication to the Principal Commissioner of Customs. Although specific comprehensive rules have not yet been notified under the health ministry, used equipment currently enters the country under an existing Ministry of Environment, Forest and Climate Change (MoEFCC) mechanism. This pathway allows the import of 38 categories of high-end equipment approved by the DGHS—including MRI systems, CT scanners, X-ray machinery, ultrasound units, and certain critical-care devices—provided they have at least seven years of residual operational life, contain no hazardous substances, and are not phased out in their country of origin.

Key Highlights

• Committee Scope: The panel is determining permissible operating ages, certification procedures, performance liabilities, and whether imports should be limited only to high-value critical-care devices.
• Current Regulatory Pathway: An MoEFCC framework presently permits the entry of 38 high-value equipment types meeting minimum 7-year lifespan criteria.
• Domestic Manufacturers’ Position: Domestic producers represented by the Association of Indian Medical Device Industry (AiMeD) caution that unregulated imports could bring obsolete equipment into the country, advocating for strict accountability, traceability, and quality benchmarks.
• Multinational Firms’ Position: Multinational medical technology bodies propose allowing imports via original equipment manufacturers (OEMs) or authorised channels to expand access to high-cost diagnostic tools in Tier-II and Tier-III cities.
• Interdepartmental Review: The health ministry has forwarded a proposal regarding MDR amendments to the MoEFCC for input.

Why This Matters

Hospitals and diagnostic facilities outside major metropolitan areas rely on pre-owned machinery to keep capital acquisition costs manageable for advanced diagnostic equipment, such as CT scanners, MRI systems, and robotic surgical setups. However, domestic device manufacturers raise concerns that relaxed import controls lacking stringent monitoring could compromise patient safety and transform India into a destination for obsolete foreign inventory. Additionally, because India lacks a dedicated import classification code for refurbished devices, calculating their exact share in nationwide medical imports remains challenging.

What to Watch Next

The health ministry is evaluating whether to amend provisions within the Medical Devices Rules to introduce a dedicated regulatory structure. Key determinations still pending include whether the government will establish an open framework with safety checks across broader device categories or restrict permissible imports strictly to very expensive, high-end critical-care tools. Feedback from the MoEFCC on the health ministry’s draft proposal is also awaited.

Frequently Asked Questions

What is the estimated value of India’s pre-owned medical equipment market?

Industry executives estimate the pre-owned medical equipment market to be worth approximately ₹1,500 crore, which accounts for nearly 10 per cent of the total medical equipment market in India.

Which refurbished medical devices are currently permitted for import?

Under an existing MoEFCC mechanism, 38 designated high-end and high-value equipment types prescribed by the DGHS can be imported. These include CT scanners, MRI systems, ultrasound and X-ray machinery, along with select laboratory and critical-care devices.

What requirements must currently imported used devices satisfy?

Imported devices must not be phased out in the exporting country, must not contain hazardous materials, and must possess a verified remaining operational life of at least seven years.

Source: Business Standard