Introduction: A Game-Changer for India’s MedTech Sector
The Indian government’s Scheme for Strengthening of the Medical Device Industry is a landmark initiative designed to boost domestic manufacturing, cut import dependence, and promote clinical evidence generation across the medical device ecosystem. pharmabiz.com
With an allocated outlay of ₹500 crore, the scheme supports key industry bottlenecks from infrastructure and skill development to investment and clinical studies over the next three years. Department of Pharmaceuticals
For IVD and medical device manufacturers, particularly those focused on quality, safety, and regulatory compliance, this scheme presents a strategic opportunity to strengthen evidence generation, enhance innovation, and gain competitive advantage.
The Scheme at a Glance: What It Covers
The Strengthening of Medical Device Industry Scheme is structured across several focused components: Department of Pharmaceuticals
1. Common Infrastructure Support
Financial assistance for testing labs, R&D facilities, and industry clusters aimed at reducing production barriers.
2. Marginal Investment Scheme for Reducing Import Dependence
Incentives to manufacture key components and raw materials domestically, helping reduce reliance on imports. pharmabiz.com
3. Capacity Building & Skill Development
Support for training programs and workforce development to build deeper technical capability within India’s MedTech workforce.
4. Medical Device Clinical Studies Support Scheme
Critical for evidence-based innovation this sub-scheme encourages clinical research by providing financial support for clinical investigations, including animal and human studies. pharmabiz.com
5. Industry Promotion
Assistance to promote events, networking, and awareness to accelerate industry growth.
Why the Clinical Studies Support Scheme Matters
Among the components, the Medical Device Clinical Studies Support Scheme carries significant value for companies undertaking regulated evidence generation:
- It provides financial support for clinical studies that can demonstrate safety, performance, and efficacy
- It lowers the economic burden of early-stage research and validation
- It aligns with global regulatory expectations for clinical data
This can be especially valuable for manufacturers working toward clinical investigations, verification studies, and performance evaluations in jurisdictions like CDSCO, EU, and US FDA.
The Opportunity for IVD and MedTech Manufacturers
India currently imports a significant portion of its medical technology needs; domestic manufacturing has historically relied on imported components and systems. Business Standard
By encouraging investment in local R&D and clinical studies through this scheme, the government is actively promoting self-reliance and evidence-based innovation.
For IVD developers and medical device manufacturers, participating in this scheme can:
- Reduce the risk and cost of clinical evidence generation
- Enable stronger regulatory submissions
- Support global market access and export strategy
- Improve product competitiveness and trust
How Bioexcel Helps You Navigate & Maximize the Scheme
While public support schemes like this provide financial and strategic impetus, successful participation depends on valid, regulator-ready evidence and strong clinical strategy.
At Bioexcel, we help manufacturers align their clinical research with regulatory priorities and scheme objectives:
Regulatory-Aligned Clinical Study Design
We support medical device clinical investigations in compliance with global standards such as ISO 14155, ensuring that studies are defensible, regulator-ready, and strategically aligned.
We support CDSCO-approved medical device clinical investigations and operate in compliance with ISO 14155 under sponsor responsibility.
Evidence Usability for Conformity & Registrations
We help ensure that data generated under supported studies can feed directly into regulatory submissions whether for Indian registration, CE marking, or other global markets.
Strategy & Submission Support
Beyond execution, we provide guidance on study planning, evidence strategy, endpoints, and regulatory risk mitigation maximizing the strategic value of the scheme for your business.
Strategic Considerations for Scheme Participation
To make the most of government support while minimizing regulatory risk:
- Start with regulatory-aligned study design, not traditional scientific design alone
- Ensure endpoints are relevant to intended use and regulatory expectations
- Plan for data integration into performance evaluation and submission dossiers
Bioexcel’s experience helps bridge these gaps, enabling evidence that stands up to regulatory review and drives value beyond the scheme’s financial incentives.
Conclusion: Turning Support into Strategic Advantage
India’s Scheme for Strengthening of the Medical Device Industry represents a pivotal moment in the country’s MedTech journey particularly for manufacturers prioritizing clinical evidence and regulatory compliance.
However, financial support alone is not enough. Companies that pair scheme participation with robust clinical and regulatory strategy are best positioned to accelerate innovation, reduce risk, and expand market access.
Bioexcel’s expertise helps you unlock that combination transforming public support into lasting competitive advantage.
