Medical Device Clinical Studies Support Scheme (MDCSSS) - SMDI

The Medical Device Clinical Studies Support Scheme (MDCSSS) operates under the Scheme for Strengthening of Medical Device Industry (SMDI), which is administered by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India. Its purpose is to support the domestic medical device manufacturing sector by encouraging the creation of high-quality devices supported by clinical evidence.

MDCSSS provides financial assistance on a reimbursement basis to generate clinical data on the safety and efficacy of medical devices and In-Vitro Diagnostics (IVDs) developed and manufactured in India. The support is intended to ease the financial load on manufacturers for pre-clinical animal studies, clinical investigations, post-market clinical follow-up, and IVD performance evaluations.

The scheme aims to strengthen the credibility and market acceptance of Indian-made medical devices in both domestic and international markets. It supports innovation and alignment with global regulatory expectations, contributing to a self-reliant medical device ecosystem. Eligible applicants include established manufacturers, IVD companies, institutes of national importance, and startups based in incubation centres affiliated with these institutions.

- **Access the SMDI Portal:** Go to the official application portal at https://smdi.lsssdc.in/. - **Fill in the Application Form:** Provide all mandatory information in the online form, including full particulars of your organisation, the proposed study, and how you meet the eligibility requirements. - **Upload Supporting Documents:** Submit the required paperwork, such as proof of a manufacturing facility in India, current regulatory approvals (Test License, CI Permission, IVD PE Permission, PMCF approval under the Medical Devices Rules 2017), detailed study protocols, project budgets, and company financial statements. - **Submit Your Application:** Send in the completed application before the stated deadline. - **Evaluation and Shortlisting:** The selection process includes assessment by the Project Management Agency (PMA), scrutiny by a Technical Committee, and ultimate clearance from the Scheme Steering Committee. - **After Selection:** Once chosen, you may begin your clinical study. Funds are released on a reimbursement basis, following completion of the study, validation of outcomes, and publication of the results.

Applications are first appraised by the Project Management Agency (PMA). A Technical Committee then reviews the proposals, assessing scientific merit, feasibility, and potential impact. Final approval rests with the Scheme Steering Committee, which ensures alignment with the broader objectives of the SMDI scheme and the Department of Pharmaceuticals. The process prioritises robust clinical methodology and relevance to the Indian medical device landscape.