Medical Device Compliance in India: CDSCO, MDR & Global Pathways

Understanding the regulatory landscape, quality expectations and global opportunities for India's medtech innovators.

Vivek Singh
Founder and CEO, TACIT MEDTEK
M. Tech (Quality), M. Pharm (Regulatory Affairs)

"Compliance should be built into the product – not added to the product at the end."

India's medical device industry is moving at an exciting pace. Startups are building powerful diagnostic tools, manufacturers are scaling advanced devices and global companies are strengthening their presence in India. But innovation is not enough; safe and effective devices must also be compliant—today in India and tomorrow in the world.

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Concept & Need → Intended Use → Classification (A, B, C, D) → Regulatory Strategy → QMS & Risk Management → Design & Development → Verification & Validation → Clinical / Perf. Evidence → Licensing → Post-market Surveillance

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Medical devices in India are classified based on risk under MDR 2017.

• Class A – Low Risk
• Class B – Low–Moderate Risk
• Class C – Moderate–High Risk
• Class D – High Risk

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Medical devices in India are regulated under the Medical Devices Rules, 2017 (MDR 2017) under the broader framework of the Drugs & Cosmetics Act.

MDR 2017 follows a risk-based classification:

• Class A: Low Risk — General controls, lower regulatory burden
• Class B: Low–Moderate Risk — Increased regulatory controls
• Class C: Moderate–High Risk — Higher level of regulatory scrutiny
• Class D: High Risk — Maximum regulatory oversight

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Software can now diagnose, monitor, assist with decisions or control devices. When it performs a medical purpose, it becomes a regulated medical device.

Key considerations include:

• Individuals' interpretation & classification
• Software (IEC 62304)
• Cybersecurity & data privacy
• Clinical/performance evidence
• AI governance and change management

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CDSCO published the "Guidance Document on Medical Device Software under MDR-2017" on 21 July 2026, providing important clarifications for software-driven medical technologies.

TACIT MEDTEK
Compliance | Quality | Global Access

Building Compliant • Quality • Globally Competitive Medical Devices