What is the primary objective of the MDCSSS scheme?

The primary objective is to support the medical device industry by fostering the development of devices backed by clinical evidence and the generation of clinical data for safety and efficacy.

Who is eligible to apply for this scheme?

Eligible applicants include medical device manufacturers and IVD manufacturers with facilities in India, Institutes of national importance (NIPERs, IISER, IITs, AIIMS, IISc), other Central Institutes/Laboratories, and startups working in incubation centres under these institutes (applying through the institute).

What is the maximum funding available?

The maximum funding available is up to ₹5 crore for clinical investigations, or up to 70% of expenditure for companies with an average turnover of less than or equal to ₹10 crore.

How is the funding disbursed?

Funding is provided on a reimbursement basis, after the completion of the study, verification of results, and publication of findings.

Are there any geographical restrictions for the studies?

Yes, all eligible studies must be conducted within India, and applicants must have a manufacturing facility in India.

Medical Device Clinical Studies Support Scheme (MDCSSS)

The Medical Device Clinical Studies Support Scheme (MDCSSS) is a crucial component of the broader Scheme for Strengthening of Medical Device Industry (SMDI), launched by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India. This initiative is designed to bolster India's medical device manufacturing sector by promoting the development of high-quality devices backed by rigorous clinical evidence.

The primary objective of the MDCSSS is to foster the generation of essential clinical data demonstrating the safety and efficacy of medical devices and In-Vitro Diagnostics (IVDs) developed and manufactured in India. By providing financial support on a reimbursement basis, the scheme aims to reduce the financial burden on manufacturers, enabling them to conduct necessary pre-clinical animal studies, clinical investigations, post-market clinical follow-up, and IVD performance evaluations.

This scheme is vital for enhancing the credibility and market acceptance of 'Made in India' medical devices, both domestically and internationally. It encourages innovation and adherence to global regulatory standards, ultimately contributing to a self-reliant and robust medical device ecosystem in the country. The program is open to a wide range of entities, including established manufacturers, IVD companies, institutes of national importance, and startups operating within incubation centers affiliated with these institutions.

The selection process for the Medical Device Clinical Studies Support Scheme is multi-layered and rigorous to ensure the selection of high-quality and impactful projects. Applications first undergo an appraisal by the Project Management Agency (PMA). Following this, a dedicated Technical Committee reviews the proposals, evaluating the scientific merit, feasibility, and potential impact of the clinical studies. Finally, the Scheme Steering Committee provides the ultimate approval, ensuring alignment with the broader objectives of the SMDI scheme and the Department of Pharmaceuticals. The focus is on robust clinical methodology and relevance to the Indian medical device landscape.

Reimbursement grant up to ₹5 crore: Post-completion funding for clinical studies, pre-clinical animal studies, PMCF, and IVD performance evaluations.
Regulatory compliance support: Funding aligned with valid permissions under Medical Devices Rules 2017 (Test Licence, CI Permission, IVD PE Permission).
'Made in India' credibility: Enables generation of clinical evidence to support market acceptance domestically and internationally.
Broad eligibility: Open to manufacturers, institutes of national importance (NIPERs, IITs, AIIMS, IISc), and incubated startups.

Medical Device Clinical Studies Support Scheme (MDCSSS) - SMDI

Medical Device Clinical Studies Support Scheme (MDCSSS) - SMDI

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