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 assumption by design — a model that continues learning after deployment is, in a meaningful sense, a different product than […]
Read MoreHow to Build an Indian Regulatory Strategy for Advanced Biologicals Before Entering the Market
The decision to enter the Indian market with an advanced Biological product should be made with a comprehensive regulatory strategy in place. India’s multi-authority regulatory environment, distinct clinical data requirements, unique quality expectations and complex commercial landscape reward companies that invest in strategic regulatory planning before beginning product development or […]
Read MoreAI in Regulatory Affairs and Clinical Development: What Pharmaceutical Companies Need to Know in 2026
Artificial intelligence is reshaping Pharmaceutical research and development, regulatory affairs, and clinical operations at a pace that few industries have previously experienced. From AI-accelerated drug discovery and predictive Clinical Trial design to AI-enabled regulatory dossier review and real-time pharmacovigilance signal detection, the technology is moving from experimental adoption into mainstream […]
Read More
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 manufacturers and Importers to keep watching it. This is called post-market surveillance, and it is becoming one of the areas […]
Read More
India as a Cosmetic Manufacturing Hub: CDSCO, BIS, and the Regulatory Enablers for Global Manufacturers
The Strategic Shift For most global Cosmetic brands, India’s regulatory journey has begun with import registration — the COS-2 pathway explored throughout this series. But for a growing cohort of global Manufacturers, India is no longer purely an import destination. It is a manufacturing location, an export base, and increasingly, […]
Read More
Post-Market Surveillance Under Medical Device Rules, 2017
Regulatory approval is often treated as the finish line. In reality, for Medical Device and IVD manufacturers in India, it marks the start of an equally demanding obligation: Post-Market Surveillance (PMS). Under the Medical Device Rules, 2017, “Post-Marketing Surveillance” means a systematic process to collect and analyse information gained from […]
Read MoreRegulation/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 21 July 2026, represents the first comprehensive regulatory guidance dedicated specifically to software-based medical technologies. Through Circular F. No. MED-16028/2/2025-office, […]
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 recombinant Biological oversight is now navigating a new wave of regulatory complexity — driven by CAR-T cell therapies, personalised medicine, […]
Regulation/Guidelines
Recall Management for Medical Devices in India
A Recall is one of the few regulatory events where speed of response directly influences both patient safety outcomes and a company’s regulatory standing. Yet many manufacturers only consider their Recall process after a Recall becomes necessary — by which point, the absence of a pre-built protocol costs valuable time, […]