medical device cluster

Centre Invites Applications for Medical Device Cluster Infrastructure Under SMDI

The Department of Pharmaceuticals (DoP), Government of India, has invited applications for the Common Facilities for Medical Devices Clusters scheme under the Scheme for Strengthening of Medical Device Industry (SMDI 2). The initiative aims to strengthen India’s medical device manufacturing ecosystem, reduce dependence on imported medical technologies, and improve access to advanced shared infrastructure for domestic manufacturers.

The scheme is expected to support the development of common facilities such as testing and calibration laboratories, sterilisation facilities, cleanrooms, tool rooms, product development centres, and specialised infrastructure required for medical device manufacturing. These shared facilities can help manufacturers access essential technical and compliance resources without making significant individual investments.

Eligible industry associations, medical device cluster developers, and government-backed organisations representing groups of manufacturers can submit applications through the official portal until 8 August 2026.

Planning to Develop a Medical Device Manufacturing Cluster?

 The initiative is expected to benefit small and medium-sized medical device manufacturers by reducing infrastructure costs, improving access to testing and certification capabilities, and supporting faster product development and regulatory compliance.

Key Highlights

  • DoP launches applications for Common Facilities for Medical Devices Clusters under SMDI 2.
  • The scheme supports shared infrastructure such as cleanrooms, testing laboratories, sterilisation units, calibration facilities, and tool rooms.
  • It complements the Marginal Investment Scheme (up to ₹10 crore capital subsidy) and the Medical Device Clinical Studies Support Scheme (MDCSS) (up to ₹5 crore reimbursement for clinical studies).
  • The objective is to reduce India’s 75–80% medical device import dependence and strengthen domestic manufacturing capabilities.

Why This Matters ?

Many MSME medical device manufacturers cannot afford advanced testing and manufacturing infrastructure individually. By creating shared facilities, the government aims to:

  • Reduce manufacturing and compliance costs.
  • Improve regulatory testing and certification capabilities.
  • Strengthen local supply chains.
  • Enhance India’s competitiveness in global medical device markets.

Industry Impact

The scheme builds on the success of clusters such as Andhra Pradesh MedTech Zone (AMTZ) and is expected to encourage similar medical device manufacturing hubs across India. If implemented effectively, it can accelerate innovation, increase domestic production, and support India’s long-term goal of becoming a global medical device manufacturing and export hub.

Strengthening India’s Medical Device Manufacturing Ecosystem

The Common Facilities for Medical Devices Clusters initiative presents an important opportunity to improve access to advanced testing, manufacturing, and compliance infrastructure. With effective planning, strong governance, and long-term operational strategies, shared facilities can reduce infrastructure costs and support the growth of domestic medical device manufacturers. Such initiatives can help strengthen local supply chains, reduce import dependence, encourage innovation, and improve India’s position in the global medical device market.

How Operon Strategist Can Help ?

Operon Strategist supports medical device manufacturers, industry associations, and cluster developers in planning and developing compliant medical device manufacturing infrastructure.

Our team provides end-to-end guidance for feasibility studies, Detailed Project Reports (DPRs), manufacturing facility planning, cleanroom design, plant layout, quality management systems, regulatory compliance, and project implementation. We help organisations develop technically feasible, compliant, and scalable infrastructure aligned with industry and government requirements.

Need Support for Medical Device Cluster Development?

Contact us to discuss your requirements.

FAQ's

It is a government initiative under SMDI 2 that provides financial support to develop shared manufacturing and testing infrastructure for medical device clusters.

Industry associations, medical device cluster developers, and eligible government-backed organisations representing medical device manufacturers.

The application deadline is 8 August 2026.

It will reduce infrastructure costs, improve access to testing and certification facilities, support regulatory compliance, and strengthen domestic manufacturing capabilities.