The Central Drugs Standard Control Organisation (CDSCO) on December 05, 2025, issued the MedTech Mitra’s In-Vitro Diagnostic INNOVATORS HANDBOOK.
This Innovators Handbook is a comprehensive guide for first-time developers of In Vitro Diagnostic (IVD) medical devices in India. It provides a structured, step-by-step overview of the processes required to develop and manufacture regulatory-compliant IVDs, helping reduce delays and confusion during product development and commercialization.
Drawing from established frameworks of the Central Drugs Standard Control Organization (CDSCO) and the Indian Council of Medical Research (ICMR), the document simplifies key legal and procedural requirements. It serves as a unified roadmap for innovators preparing for performance validation, regulatory submissions, and market entry.
A notable feature of the handbook is the To-Do Lists at the end of each chapter, offering practical, sequential guidance on critical areas such as device classification, performance evaluation, risk assessment, QMS compliance, and post-market surveillance. These tools help ensure that IVDs meet mandated standards of safety, efficacy, and quality.
The handbook also emphasizes early regulatory engagement and strategic compliance planning. It underscores the importance of robust verification and validation practices, ensuring that validation requirements are proportionate to the risk level posed by the IVD to users, patients, and public health.
