Scheme for Strengthening of Medical Device Industry (SMDI)

About the Scheme for Strengthening of the Medical Device Industry (SMDI)

• About: It is a scheme to boost the medical device industry in India. 
• Launched by: It was launched by the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilisers in 2024.  
• Aim: It aimed at strengthening key areas such as manufacturing, skill development, clinical studies, infrastructure, and industry promotion.
• Budget outlay: It has a budget outlay of Rs 500 crore. 
• Duration: It is implemented for over three years, until the financial year 2026-27.
• Sub-schemes: The two sub-schemes, Assistance to Medical Device Clusters for Common Facilities and Human Resource Development in the Medical Device Sector, have become part of the single scheme – SMDI.
• Components: The scheme has five components, which are as follows:
  • Common Facilities for Medical Device Clusters: Develop shared infrastructure and testing facilities to strengthen manufacturing and ensure compliance with regulatory requirements.
  • Marginal Investment Scheme for Reducing Import Dependence: Provide grants to support domestic manufacturing of essential medical device components, materials, accessories, and related products that are currently imported.
  • Capacity Building and Skill Development in the Medical Device Sector: Enhances education, training, research, and R&D to create a skilled workforce for the sector.
  • Medical Device Clinical Studies Support Scheme (MDCSS): Support will be provided for conducting Clinical Investigations or Pre-Clinical animal studies for medical devices or Clinical Performance Evaluation of new IVDs.
  • Medical Device Promotion Scheme: The scheme aims to promote the medical device industry by bringing industry leaders, academia and policy makers together to share their knowledge and experience for the overall development of the sector.
• Eligible entities under SMDI:
  • An entity could apply for more than one project, “provided each project is distinct, independently viable, and meets the scheme’s objectives of reducing import dependence.”
  • Each project will be evaluated and approved separately, and the financial assistance limit (maximum ₹10 crore) applies per project.
• What the selected entity will get under the Marginal Investment Scheme for Reducing Import Dependence: Those selected would receive a one-time capital subsidy of up to ₹10 crore on a reimbursement basis for manufacturing key components/raw materials/finished devices/accessories to reduce import dependence under the Marginal Investment Scheme.
• What the selected entity will get under MDCSS: The selected entity will get financial support of up to ₹5 crore under MDCSS Scheme for conducting clinical investigation/clinical performance evaluation/Post Market Follow-up Study/animal studies to the eligible applicants on a reimbursement basis.