India’s Medical Devices Sector: PLI Progress & 2026 Outlook

India’s medical devices sector enters 2026 with strong momentum as the PLI scheme drives domestic manufacturing, exports, and investment. Explore policy progress, market outlook, and strategic opportunities for investors and global supply chains.

As India enters 2026, its medical devices sector stands at an inflection point. The convergence of targeted manufacturing incentives, regulatory consolidation, and sustained healthcare demand is shifting the industry from policy ambition to operational reality, with implications for investors, manufacturers, and global supply chains through the remainder of the decade.

What was historically a heavily import-dependent market is gradually transitioning toward a manufacturing-led and export-capable ecosystem.

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The Production Linked Incentive (PLI) Scheme for Promoting Domestic Manufacturing of Medical Devices has moved beyond policy intent and into measurable execution. Greenfield manufacturing projects have been commissioned, high-end devices are being produced locally for the first time, and exports of Indian-manufactured devices have begun to scale.

For sector investors, operating companies, and industry supply chain stakeholders, 2026 is shaping up not as an experimental phase, but as a year of commercial validation and strategic positioning – with decisions taken now likely to define competitiveness through 2030 and beyond.

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India’s medical devices market: Where the sector stands at the end of 2025

India’s medical devices market is estimated at approximately US$14–16 billion as of 2025, accounting for a relatively small share of the global MedTech industry. However, government and industry projections consistently indicate growth toward US$30–50 billion by 2030, supported by structural demand drivers that are expected to remain intact through the second half of the decade.

Key demand fundamentals entering 2026 include:

• Continued expansion of hospital and diagnostics infrastructure across Tier-2 and Tier-3 cities
• Rising prevalence of non-communicable diseases, driving demand for diagnostics, imaging, and implantable devices
• Increasing insurance penetration and public healthcare spending
• Greater adoption of technology-enabled healthcare delivery models

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Despite these demand tailwinds, import dependence remains significant, particularly for high-technology segments such as diagnostic imaging, oncology equipment, implants, and critical-care devices. It is precisely this gap that India’s current industrial policy framework seeks to address.

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The PLI Scheme for Medical Devices: Progress achieved in 2025

Scheme design and strategic intent

The PLI Scheme for Promoting Domestic Manufacturing of Medical Devices, launched with a total outlay of INR 34.20 billion, provides incentives at the rate of 5 percent on incremental sales of domestically manufactured medical devices over a five-year performance period (FY 2022–23 to FY 2026–27).

The scheme focuses on four product segments that historically account for a disproportionate share of India’s medical device imports:

1. Cancer care and radiotherapy devices
2. Radiology and imaging equipment (ionizing and non-ionizing) and nuclear imaging devices
3. Anesthetics and cardio-respiratory medical devices, including renal care
4. All implants, including implantable electronic devices

The strategic objective has been to catalyze complex manufacturing, reduce import dependence, and position India as a competitive production base within global MedTech value chains.

Execution outcomes to date

As confirmed by official government updates released in 2025, the PLI scheme has delivered tangible manufacturing and market outcomes:

• Twenty-two greenfield manufacturing projects have been commissioned under the scheme.
• Production has commenced for more than 55 medical devices, including MRI scanners, CT scanners, mammography systems, C-arm X-ray machines, ultrasound equipment, MRI coils, and linear accelerators (LINACs).
• As of September 2025, cumulative eligible sales under the PLI scheme reached approximately INR 123.44 billion.
• Of this, exports accounted for around INR 58.69 billion, indicating early success in placing Indian-manufactured devices into international markets.

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Both multinational and Indian manufacturers have participated actively. Investments by firms such as Siemens Healthcare, Philips, Allengers Medical Systems, Panacea Medical Technologies, and BPL Medical Technologies have resulted in local production of devices that were previously almost entirely imported.

Importantly, the government has also expanded participation by introducing a Category-B eligibility stream in 2023, which lowered investment and sales thresholds to encourage entry by smaller and mid-sized manufacturers. The move is also hoped to promote wider industrial participation across device segments where emerging players may have innovation or niche capabilities.

What the PLI outcomes mean strategically heading into 2026

From a sector strategy perspective, the PLI scheme’s progress has created several structural shifts that will shape the industry’s trajectory in 2026.

1. Transition from assembly to complex manufacturing

The localization of MRI, CT, and radiotherapy equipment represents a qualitative shift in India’s manufacturing capability. These are not low-risk, commoditized products, but devices that require advanced engineering, stringent quality systems, and regulatory compliance.

This transition materially improves India’s ability to capture higher value within the medical devices supply chain.

2. Export viability is being demonstrated

Export volumes under the PLI scheme, while still early-stage, suggest that Indian-manufactured devices are increasingly meeting global buyer requirements, particularly in emerging markets across Asia, Africa, and the Middle East.

For global OEMs and supply chain partners, this reinforces India’s potential role as an export-oriented manufacturing base, not merely a domestic market play.

3. Cluster-based ecosystems are taking shape

PLI investments are increasingly aligning with medical device clusters and parks, supported by parallel infrastructure schemes at the state level. This clustering effect improves access to skilled labor, supplier networks, testing facilities, and logistics – critical for scaling operations beyond the incentive window.

Regulatory and infrastructure environment entering 2026

By the end of 2025, India’s regulatory framework for medical devices has reached a higher degree of clarity and stability:

• The Medical Devices Rules, 2017 now function as a standalone regulatory regime with risk-based classification.
• Digital licensing systems and published timelines have improved transparency, though execution quality remains dependent on application readiness.
• Medical device parks in Uttar Pradesh, Tamil Nadu, Madhya Pradesh, and Himachal Pradesh are gradually operationalizing shared infrastructure for testing, validation, and common services.

For investors and manufacturers entering in 2026, regulatory preparedness and quality-system maturity will be decisive differentiators, particularly for export-oriented strategies.

Advisory: Where medical device investors and businesses should focus in 2026

Import substitution with long-term export potential

The strongest opportunities remain in segments where import dependence is high, but domestic manufacturing capability has now been established:

• Diagnostic imaging systems and sub-assemblies
• Oncology and radiotherapy platforms
• Implantable devices and advanced consumables
• Renal care and cardio-respiratory devices

These segments offer a dual pathway: immediate domestic demand and medium-term export growth.

Component and sub-assembly localization

While final-device manufacturing has accelerated, upstream localization remains uneven. This creates strategic openings for:

• Sensors, electronics, and printed circuit boards
• Precision machining and medical-grade plastics
• Coils, detectors, and power systems

For global suppliers reassessing supply chain concentration risks, India presents a viable China-plus-one or diversification node as of 2026.

Manufacturing services and ecosystem plays

Beyond device production itself, opportunities are emerging in:

• Contract manufacturing and OEM partnerships
• Testing, calibration, and certification services
• Regulatory, clinical, and quality-assurance consulting
• Device-software integration and digital health enablement

These services will be critical as more manufacturers seek regulatory clearance in global markets.

Key risks and strategic watchpoints

As stakeholders plan for 2026 and beyond, several risks merit close attention:

• Post-PLI sustainability: As the PLI scheme concludes in FY 2026–27, investors engaging with PLI beneficiaries and larger firms partnering with them must assess whether cost structures, pricing power, and margins remain sustainable once incentive support tapers off.
• Regulatory execution and compliance risk: While India’s medical device regulatory framework has matured, approval timelines and audit outcomes remain highly dependent on application quality and regulatory engagement. Export-oriented strategies require early investment in robust quality management systems and regulatory readiness.
• Quality and global market access: Scaling exports beyond emerging markets will require consistent adherence to international standards, including ISO 13485 and CE/FDA pathways. Gaps in clinical evidence, documentation, or post-market surveillance could constrain access to regulated markets.
• Supply-chain depth and component dependence: Despite progress in final-device manufacturing, limited localization of critical components may restrict margin expansion and expose manufacturers to input-cost volatility or external supply disruptions.
• Pricing oversight and policy intervention: Devices classified as essential remain subject to price monitoring and regulatory oversight. Investors should factor potential pricing constraints into revenue forecasts, particularly in high-volume therapeutic segments.
• Capital intensity and scale risk: Advanced medical device manufacturing requires sustained capital investment in equipment, talent, and compliance infrastructure. Sub-scale operations may struggle to achieve operating leverage in the absence of continued policy support.
• Cluster execution risk: While medical device parks and clusters offer long-term advantages, their effectiveness will vary by location. Investors should assess on-the-ground readiness of infrastructure, utilities, testing facilities, and supplier ecosystems rather than relying solely on policy announcements.

Mitigating these risks requires early planning, phased localization strategies, and alignment with well-developed clusters.

India’s medical device sector outlook to 2030

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Looking ahead, the foundations laid by the PLI scheme suggest that 2026–2030 will be a consolidation and scale-up phase for India’s medical device production rather than a policy-driven expansion cycle.

Success in the next phase will depend on:

• Deepening component-level manufacturing
• Strengthening export regulatory credentials
• Expanding R&D and design engineering capabilities
• Integrating MSMEs into larger supply chains

If these conditions are met, India is positioned to emerge as a globally relevant MedTech manufacturing hub by the end of the decade.

Conclusion

India’s medical devices sector is entering 2026 with clear evidence of policy execution, manufacturing capability, and export traction. The progress achieved under the PLI Scheme marks a structural shift in how India participates in the global MedTech industry.

For investors, businesses, and supply chain stakeholders, the strategic question is no longer whether India can support advanced medical device manufacturing – but how to integrate into this ecosystem early enough to capture value through 2030 and beyond.

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