Regulatory Perspectives on Risk-based Monitoring in Clinical Trials of High-risk Medical Devices in India: a Review
Year: 2026
Type: article
Abstract: Clinical investigations of high-risk medical devices generate essential evidence for regulatory decisions concerning implanted, life-supporting, and potentially harmful devices. Traditional monitoring approaches, characterized by frequent on-site visits and extensive source data verification (SDV), are resource-intensive and may provide limited additional value in detecting critical errors. Risk-based monitoring (RBM), supported by risk-based quality management (RBQM), focuses monitoring activities on processes and data essential for participant safety and trial reliability. International regulatory bodies, including the International Council for Harmonisation (ICH), US Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Organization for Standardization (ISO), support risk-proportionate quality management. In India, clinical investigations are governed by the Medical Devices Rules, 2017, administered by the Central Drugs Standard Control Organisation (CDSCO); however, dedicated provisions for RBM remain limited. This review examines global and Indian regulatory approaches to RBM in Class C and D medical device investigations. It discusses key components, including risk assessment, key risk indicators, quality tolerance limits, centralized monitoring, and targeted source data review. Published evidence regarding effectiveness, costs, and operational benefits is evaluated alongside device-specific challenges, implementation barriers, and emerging technologies such as electronic data capture, artificial intelligence, wearable sensors, and decentralized clinical trials. Traditional and risk-based monitoring approaches are compared, and a roadmap for integrating RBM into India's regulatory framework is proposed. RBM represents a scientifically justified and regulatorily supportable approach for high-risk medical device investigations, provided that a device-specific, CDSCO-aligned framework ensures documented risk assessment, proportionate monitoring, participant protection, data integrity, and auditable oversight.
Authors: Aditya, Divya Chugh
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7224768117