BIS

Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Second Amendment Order, 2025

Posted by: Prabhas Chakraborty November 21, 2025

7
Comments Off on Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Second Amendment Order, 2025
21st November, 2025

What's New 2?

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...