Medical Device Clinical Studies Support Scheme (MDCSSS) - SMDI

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.