Medical Device Clinical Studies Support Scheme (MDCSSS) - SMDI

The Medical Device Clinical Studies Support Scheme (MDCSSS) is a component of the broader Scheme for Strengthening of Medical Device Industry (SMDI). Launched by the Department of Pharmaceuticals under the Ministry of Chemicals & Fertilizers, Government of India, it aims to boost the domestic medical device manufacturing sector by funding clinical evidence generation.

The scheme provides financial support on a reimbursement basis for pre-clinical animal studies, clinical investigations, post-market clinical follow-up (PMCF), and IVD performance evaluations. By reducing the financial burden, it encourages manufacturers to generate rigorous safety and efficacy data, enhancing the credibility of 'Made in India' devices globally. Eligible entities include manufacturers with facilities in India, institutes of national importance, and startups in incubation centres of such institutes.

• Reimbursement grant up to ₹5 crore
• Supports clinical studies for medical devices and IVDs
• Open to manufacturers, institutes, and startups
• Project duration of 3 years
• Focus on 'Made in India' medical devices

Applicants must be medical device or IVD manufacturers with a manufacturing facility in India. Also eligible are institutes of national importance such as NIPERs, IISER, IITs, AIIMS, and IISc, as well as other central institutes and laboratories. Startups operating within incubation centres under these institutes may apply through the institute. Applicants must hold valid regulatory permissions as per the Medical Devices Rules 2017, including Test License, CI Permission, IVD PE Permission, or PMCF approval, depending on the study type. All studies must be conducted within India, and co-financing is required since funding is provided as reimbursement covering a percentage of total expenditure.

Medical Device Clinical Studies Support Scheme (MDCSSS) - SMDI is open to startups at any stage. It is open to startups registered anywhere in India.

Applications for Medical Device Clinical Studies Support Scheme (MDCSSS) - SMDI are open and the current deadline is Closes in 9d (24 Jul 2026). Applications are closing soon, so prepare your documents early. Deadlines can change — always reconfirm on the official source before submitting.

Funding is provided as a reimbursement grant of up to ₹5 crore per project. For companies with an average turnover of ₹10 crore or less, the grant covers up to 70% of eligible expenditure. The scheme supports pre-clinical animal studies, clinical investigations, post-market clinical follow-up (PMCF), and IVD performance evaluations. Financial assistance is disbursed after study completion, verification of results, and publication of findings. The project duration is up to 3 years.

Medical Device Clinical Studies Support Scheme (MDCSSS) - SMDI is offered by Department of Pharmaceuticals, a government body. As a government-backed subsidy, it is publicly funded and open to eligible startups across India. You can verify current details and timelines on the provider's official website before applying.

Applications are first appraised by the Project Management Agency (PMA). A Technical Committee then reviews the proposals for scientific merit, feasibility, and potential impact. Finally, the Scheme Steering Committee gives the ultimate approval, ensuring alignment with the SMDI scheme's objectives.

Before you apply to Medical Device Clinical Studies Support Scheme (MDCSSS) - SMDI, keep the following documents ready:

• A pitch deck or short business plan describing the problem, product and traction
• Company registration documents and PAN
• Founder identification (PAN / Aadhaar) and brief profiles
• Recent financial statements or projections
• Product details — a demo, prototype or working link if available

Exact requirements are confirmed on the official application portal — treat this as a preparation checklist.

Medical Device Clinical Studies Support Scheme (MDCSSS) - SMDI is best suited for startups in India seeking non-dilutive funding of ₹5Cr. If that describes your startup, review the eligibility criteria above before applying.