Medical Device Clinical Studies Support Scheme (MDCSSS) - SMDI

The Medical Device Clinical Studies Support Scheme (MDCSSS) sits within the wider Scheme for Strengthening of Medical Device Industry (SMDI). The Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India, runs both. Through the scheme, India's medical device manufacturing sector is encouraged to build devices supported by solid clinical evidence.

MDCSSS exists to generate the clinical data needed to show that medical devices and In-Vitro Diagnostics (IVDs) made in India are safe and effective. Support comes as reimbursement, which lowers the cost burden on manufacturers. That money covers pre-clinical animal studies, clinical investigations, post-market clinical follow-up, and IVD performance evaluations.

The scheme helps 'Made in India' medical devices win trust and acceptance in domestic and international markets. It pushes innovation and compliance with global regulatory standards, feeding into a self-reliant medical device ecosystem.

Eligibility extends to established manufacturers, IVD companies, institutes of national importance, and startups based in incubation centres attached to such institutions.

- **Access the SMDI portal:** Go to the official application site at https://smdi.lsssdc.in/. - **Fill in the application form:** Provide all mandatory particulars online, covering details of your organisation, the study you propose to undertake, and how you meet the eligibility criteria. - **Upload supporting documents:** Attach the papers required, namely evidence of a manufacturing facility located in India, valid regulatory permissions (Test License, CI Permission, IVD PE Permission, PMCF approval under Medical Devices Rules 2017), full study protocols, project budgets, and the company's financial statements. - **Send in the application:** Lodge your completed application before the stated deadline. - **Appraisal and selection:** Each application passes through a selection process comprising appraisal by the Project Management Agency (PMA), scrutiny by a Technical Committee, and final sanction by the Scheme Steering Committee. - **After selection:** Those selected may begin the clinical study. Funds are released as reimbursement once the study is finished, results are verified, and findings are published.

Applications are first appraised by the Project Management Agency (PMA). A dedicated Technical Committee then examines each proposal, assessing its scientific merit, feasibility and likely impact. Final approval rests with the Scheme Steering Committee, which confirms that projects align with the wider objectives of the SMDI scheme and the Department of Pharmaceuticals.