Introduction: Medical Device Manufacturing in India at a Turning Point
Medical Device Manufacturing in India is undergoing a major transformation under the Make in India initiative. With strong government support, policy reforms, and targeted incentives, India is positioning itself as a global manufacturing hub for high-quality, affordable medical devices. In 2026, this sector represents one of the most promising opportunities for domestic and international manufacturers looking to reduce costs, scale production, and access global markets.
India currently imports a significant share of its medical devices, especially high-end diagnostic and life-saving equipment.
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Government Strategy Behind Make in India for Medical Devices
The Government of India, along with NITI Aayog, has developed a comprehensive roadmap to promote Medical Device Manufacturing in India. This strategy aligns with successful policy models used in the electronics and telecom sectors.
Key Objectives of the Initiative
- Reduce dependency on imported medical devices
- Improve affordability and accessibility of healthcare technologies
- Encourage foreign direct investment (FDI)
- Promote innovation and indigenous manufacturing
- Build export-ready manufacturing infrastructure
The policy framework includes financial incentives, simplified regulatory pathways, and infrastructure development through dedicated medical device parks.
Incentives and Benefits for Medical Device Manufacturers
To accelerate growth, the government offers multiple incentives under Make in India and related schemes.
Major Incentives Available
- Production Linked Incentive (PLI) Scheme for medical devices
- Capital subsidies for manufacturing infrastructure
- Tax benefits and reduced import duties on components
- Support for R&D and product innovation
- 100% FDI allowed under the automatic route
These incentives make India a competitive alternative to traditional manufacturing hubs while maintaining quality and regulatory compliance.
Priority Medical Devices Under Make in India
The Make in India program follows a phased approach to medical device localization.
Phase 1: High-Volume and Essential Devices
- Diagnostic and imaging equipment
- In-vitro diagnostic (IVD) products
- Cancer and cardiac screening devices
Phase 2: Advanced and Critical Care Devices
- Pacemakers and cardiac implants
- Ventilators and respiratory devices
- Dialysis machines
- CT scanners and advanced imaging systems
This structured approach allows manufacturers to scale operations while meeting both domestic and international demand.
Regulatory Framework for Medical Device Manufacturing in India
Regulatory compliance is a critical success factor for Medical Device Manufacturing in India. All manufacturers must comply with the Medical Device Rules, 2017, regulated by the Central Drugs Standard Control Organization (CDSCO).
Key Regulatory Requirements
- CDSCO manufacturing license based on device classification
- ISO 13485 Quality Management System certification
- Compliance with applicable BIS standards
- Clinical evaluation and performance data
- Post-market surveillance and vigilance systems
Early regulatory planning significantly reduces approval timelines and prevents costly delays.
Why Global Companies Are Choosing India
India has emerged as a preferred destination for medical device manufacturing due to its strategic advantages.
Key Reasons
- Large and growing healthcare market
- Cost-effective skilled workforce
- Government-backed incentive schemes
- Strong export potential to emerging and regulated markets
- Improving regulatory transparency
Despite global discussions around price controls, India continues to attract long-term investments from global medical technology companies.
Challenges and How the Government Is Addressing Them
The government is actively working to overcome challenges that previously slowed sector growth.
Key Challenges Being Addressed
- Complex approval processes
- Dependence on imported raw materials
- Limited testing and calibration infrastructure
Dedicated medical device parks, regulatory digitization, and infrastructure investments are helping India close the gap with global leaders such as China.
Planning to Start Medical Device Manufacturing in India?
How Operon Strategist Supports Medical Device Manufacturers
Operon Strategist provides end-to-end consulting support for companies planning to establish or expand medical device manufacturing operations in India.
Our Expertise Includes
- CDSCO manufacturing license support
- ISO 13485 and quality system implementation
- Cleanroom and facility compliance
- Regulatory documentation and submissions
- Global market approval strategy
We help manufacturers move efficiently from concept to compliant commercialization.
FAQs
Is Medical Device Manufacturing allowed under Make in India?
Yes, medical devices are a priority sector under Make in India, supported by PLI schemes and policy incentives.
Which authority regulates medical devices in India?
Medical devices are regulated by the CDSCO under the Medical Device Rules, 2017.
Is ISO 13485 mandatory for manufacturers?
Yes, ISO 13485 certification is mandatory for quality management and regulatory compliance.
Can foreign companies manufacture medical devices in India?
Yes, 100% FDI is permitted under the automatic route for medical device manufacturing.
How long does CDSCO approval take?
Approval timelines typically range from 6 to 9 months, depending on device class and documentation readiness.
