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Software as a Medical Device (SaMD) – India’s Regulatory Stance

Posted by: Mahima Sahrawat August 18, 2026

Although software intended for Medical purposes h

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18th August, 2026

Regulatory Challenges of SaMD: Navigating Global Standards and Compliance

Posted by: Neha Gupta November 4, 2024

Overview Navigating Software as a Medica

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4th November, 2024

The Future of SaMD: Emerging Trends and Innovations

Posted by: Neha Gupta November 4, 2024

Overview The future of (SaMD) Software a

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4th November, 2024

Understanding SaMD: What Makes Software a Medical Device?

Posted by: Neha Gupta November 4, 2024

Overview Software as a Medical Device re

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4th November, 2024

Quality Management Systems for SaMD: Best Practices and Standards

Posted by: Neha Gupta October 22, 2024

Overview Quality Management Systems for

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22nd October, 2024

Clinical Validation of SaMD: What You Need to Know

Posted by: Neha Gupta October 22, 2024

Overview Clinical validation of Software

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22nd October, 2024

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Regulation/Guidelines

AI/ML-Based Medical Devices — Emerging Regulatory Questions

Traditional Medical Device regulation assumes a fixed product: what’s approved is what ships, indefinitely, until a formal change is filed and reviewed. Adaptive AI and machine learning algorithms break that...

24th August, 2026

Regulation/Guidelines

Post-Market Surveillance for Cosmetics in India: What CDSCO Expects After Launch

Getting a Cosmetic product registered and onto shelves in India is only half the job. Once a product is in the market, the Cosmetics Rules, 2020 place ongoing duties on...

19th August, 2026

Regulation/Guidelines

Software as a Medical Device (SaMD) – India’s Regulatory Stance

Although software intended for Medical purposes has been regulated in India since the implementation of MDR, 2017 Rules. CDSCO's Guidance Document on Medical Device Software (Doc No. CDSCO/MD/GD/MDSW/01/2026), issued on...

18th August, 2026

Regulation/Guidelines

The Future of Biological Regulation in India: Biosimilars, CAR-T, AI & Advanced Therapies

India's Biological Regulatory landscape is at an inflection point. The country that pioneered affordable Biosimilar access, built one of the world's largest vaccine manufacturing ecosystems, and established the framework for...