Medical Device Clinical Studies Support Scheme (MDCSSS)
Financial support for clinical validation of Indian medical devices and IVDs through reimbursement-based assistance.
About the Program
The Medical Device Clinical Studies Support Scheme (MDCSSS), under the Strengthening of Medical Device Industry (SMDI) initiative, provides financial support to Indian medical device and IVD manufacturers for generating clinical evidence required for regulatory approvals and commercialization. The scheme supports pre-clinical studies, clinical investigations, Post-Market Clinical Follow-up (PMCF) studies, and IVD performance evaluations through reimbursement-based financial assistance.
Eligibility requirements
- Indian medical device and IVD manufacturers.
- Applicants conducting eligible pre-clinical or clinical validation studies.
- Support is provided as reimbursement based on applicable scheme guidelines and eligible expenditure.
Offerings / Benefits
- Financial support up to INR 5 Crore for Clinical Investigations.
- Financial support up to INR 2 Crore for Pre-clinical Studies.
- Financial support up to INR 1 Crore for PMCF Studies.
- Financial support up to INR 1 Crore for IVD Performance Evaluation.
- Supports regulatory approvals and commercialization.
- Reduces clinical validation costs.
- Strengthens clinical evidence generation.
- Supports Make in India and import substitution.
Sectors supported
Selection process
- Not specified.
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