India Medical Devices Regulations – Where India Stands in 2025
Aakash Jindal, for AptSkill
Executive Summary
India's medical device industry, once considered nascent and heavily import-reliant, is
undergoing transformative regulatory maturation. As of 2025, with the full implementation of
the Medical Device Rules (MDR) 2017 and progressive reforms from the Central Drugs
Standard Control Organization (CDSCO), India has entered a new era of quality, compliance,
and global competitiveness in the MedTech sector. This whitepaper provides a comprehensive
exploration of the regulatory framework, current state, progress, challenges, and what the
future holds for medical device regulation in India.
Table of Contents
1. Introduction
2. Regulatory Governance Framework
3. Medical Device Rules, 2017: A Foundation
4. Classification of Medical Devices
5. Licensing Landscape: Import, Manufacturing & Sale
6. Clinical Investigations & IVD Performance Evaluation
7. Role of Notified Bodies
8. Labelling, UDI & Shelf-life Requirements
9. Regulatory Milestones Achieved (2017–2025)
10. Challenges & Gaps
11. India's Position in Global MedTech Regulatory Landscape
12. The Road Ahead – Recommendations for Stakeholders
13. Conclusion
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1. Introduction
India is among the top 20 global medical device markets and the fourth largest in Asia. With
over 75% of its devices being imported as of 2020, the Indian government launched a
regulatory transformation through the Medical Device Rules, 2017, later expanded in 2020 to
regulate all devices. By 2025, India is no longer a passive importer but is establishing itself as
a MedTech manufacturing and regulatory hub.
2. Regulatory Governance Framework
CDSCO – India’s National Regulatory Authority
The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and
Family Welfare, is the Central Licensing Authority (CLA) for medical devices. Key features:
• Headquartered in New Delhi with zonal, sub-zonal, and port offices.
• Supported by 20+ drug testing laboratories nationwide.
• Functions alongside State Licensing Authorities (SLAs) for Class A and B device
licensing.
3. Medical Device Rules, 2017: A Foundation
Effective January 1, 2018, MDR 2017 represents India’s first dedicated regulatory framework
for medical devices. Its core principles include:
• Risk-based classification (Class A–D)
• ISO 13485-aligned Quality Management System (QMS)
• Essential Principles of Safety and Performance
• Provisions for clinical investigations and notified bodies
• Introduction of Unique Device Identification (UDI)
CDSCO notifications in 2020 expanded the regulatory scope to cover all medical devices,
including software and digital health technologies.
4. Classification of Medical Devices
India follows a risk-based classification system in alignment with international norms:
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Risk Class Description Regulatory Oversight
Class A Low risk SLA
Class B Low to moderate risk SLA + NB
Class C Moderate to high risk CLA
Class D High risk CLA
Similarly, IVDs are classified from A to D based on diagnostic impact.
5. Licensing Landscape: Import, Manufacturing & Sale
Manufacturing
• Class A & B: Licensed by SLA; Class A requires no prior audit.
• Class C & D: Licensed by CLA after inspection/audit.
Import
• Requires import license (Form MD-15), granted upon submission of performance
data, FSCs, and clinical trial data where needed.
Clinical Investigation & Test Licenses
• Test License (Form MD-12/13 or MD-16/17) allows limited manufacturing/import for
R&D, evaluation, or training.
• Clinical trials governed under GCP, Ethics Committees (registered), and Schedule
Y/NDCT Rules.
6. Clinical Investigations & IVD Performance Evaluation
India’s MDR includes comprehensive guidance on:
• Clinical Investigations (Form MD-22 to MD-23)
• Clinical Performance Evaluation (Form MD-24 to MD-25)
• Post-approval surveillance, reporting, and compensation mechanisms (R.55, R.62)
For IVDs, performance evaluation through Central MDTL or approved labs is mandatory.
7. Role of Notified Bodies
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Notified Bodies (NBs) are accredited organizations that assess QMS compliance for:
• Class A (for export)
• Class B devices (mandatory pre-license audit)
Key functions:
• Independent audits
• No conflict of interest or training for clients
• Accreditation via National Accreditation Board (NAB)
As of 2025, many NBs are eligible to handle Class C & D devices based on performance
reviews.
8. Labelling, UDI & Shelf-life Requirements
Labelling (Rule 44)
• Mandatory details include name, intended use, manufacturer info, batch/lot, expiry,
storage, warnings, and license number.
Unique Device Identification (UDI)
Mandatory since Jan 1, 2022:
• Device Identifier (DI): Static
• Production Identifier (PI): Batch/serial, manufacture/expiry dates
Shelf-Life Controls
Import controls based on residual shelf-life ensure patient safety and product effectiveness.
9. Regulatory Milestones Achieved (2017–2025)
Year Milestone
2017 MDR 2017 implemented for 24 device categories
2020 All devices notified as medical devices under new definition
2022 UDI becomes mandatory
2023 Digitization of application process via CDSCO SUGAM portal
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Year Milestone
2024 80+% of medical devices under regulatory scope
2025 CDSCO launches National Device Registry and centralized vigilance portal
10. Challenges & Gaps
Despite progress, India faces notable challenges:
• Limited awareness among domestic manufacturers about compliance requirements.
• Shortage of notified bodies relative to number of devices entering regulation.
• Disparity in SLA capabilities across states.
• Delayed adoption of global standards like IEC 60601, ISO 14155.
• Lack of harmonization with U.S. FDA and EU MDR pathways.
11. India's Position in Global MedTech Regulatory Landscape
Parameter India (2025) EU MDR US FDA
Classification Risk-based (A-D) Risk-based (I-III) Risk-based (I-III)
QMS Standard ISO 13485 ISO 13485 21 CFR 820
UDI Mandatory Mandatory Mandatory
Clinical Requirements Aligned with ISO 14155 Very stringent Stringent
Digital Portal CDSCO SUGAM EUDAMED FDA ESG
Coverage 100% (notified MDs) Full Full
India is moving toward regulatory convergence, especially via its participation in the IMDRF
and bilateral dialogues with ASEAN, WHO, and WHO-PQ programs.
12. The Road Ahead – Recommendations for Stakeholders
For Indian Manufacturers:
• Proactively classify devices and initiate licensing for non-notified products.
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• Invest in ISO 13485 QMS, biocompatibility, and validation studies.
• Prepare for Clinical Evaluation Reports (CERs) and Post-market Surveillance (PMS).
For Regulators:
• Enhance capacity-building of SLAs.
• Accelerate training and accreditation of new Notified Bodies.
• Foster regulatory sandboxes for innovation (e.g., SaMD, AI/ML devices).
For Training Platforms like AptSkill:
• Develop skill certification programs in:
o Device Classification
o Clinical Evaluation & Investigation
o Regulatory Submissions (MD-Forms)
o Labelling & UDI implementation
• Offer practical workshops on dossier preparation and audits.
13. Conclusion
India’s medical device regulatory journey is steadily aligning with global best practices. While
challenges remain, the regulatory system under MDR 2017 has matured significantly. By
2025, India stands at a pivotal moment—poised to become a major MedTech manufacturing
hub and regulatory model for other emerging economies. Platforms like AptSkill are key to
skilling the next generation of MedTech professionals to ensure regulatory readiness,
innovation, and quality compliance.
Learning never stops at AptSkill
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