Medical Device Clinical Studies Support Scheme (MDCSSS) - SMDI

The Medical Device Clinical Studies Support Scheme (MDCSSS) forms part of the wider Scheme for Strengthening of Medical Device Industry (SMDI), introduced by the Department of Pharmaceuticals under the Ministry of Chemicals & Fertilizers, Government of India. Its purpose is to strengthen domestic manufacturing of medical devices by encouraging the creation of high-quality products supported by dependable clinical evidence.

Financial assistance is provided on a reimbursement basis to help manufacturers generate data on the safety and efficacy of medical devices and In-Vitro Diagnostics (IVDs) developed and produced in India. The support covers pre-clinical animal studies, clinical investigations, post-market clinical follow-up, and IVD performance evaluations, easing the cost burden on companies.

The scheme aims to improve the credibility and acceptance of Indian-made medical devices in both domestic and international markets. It promotes innovation and compliance with global regulatory norms, contributing to a self-sufficient medical device sector. Eligible applicants include established manufacturers, IVD firms, institutes of national importance, and startups operating within incubation centres linked to these institutions.

Access the SMDI portal at https://smdi.lsssdc.in/ and complete the online application form with full particulars of your organisation, the proposed study, and how you meet the eligibility requirements. Upload the necessary documents, such as proof of a manufacturing facility in India, valid regulatory approvals (Test License, CI Permission, IVD PE Permission, PMCF approval under the Medical Devices Rules 2017), detailed study protocols, project budgets, and company financials. Submit the application before the stated deadline. The selection process involves appraisal by the Project Management Agency (PMA), review by a Technical Committee, and final approval by the Scheme Steering Committee. If selected, you may proceed with the clinical study; funds are released on a reimbursement basis once the study is completed, results are verified, and findings are published.

Applications are first assessed by the Project Management Agency (PMA). A Technical Committee then reviews each proposal, weighing its scientific merit, feasibility, and likely impact. Final approval rests with the Scheme Steering Committee, which checks that the project aligns with the SMDI scheme’s wider goals and the Department of Pharmaceuticals. The review prioritises sound clinical methodology and relevance to India’s medical device sector.