MedTech Mitra’s In-Vitro Diagnostic Innovators Handbook

The MedTech Mitra IVD Innovators Handbook is a structured guidance resource developed jointly by ICMR and CDSCO (IVD Division) to help stakeholders plan regulation-compliant development of in‑vitro diagnostic medical devices in India. It explains key steps from clinical need assessment and intended use definition to risk-based IVD classification (Class A–D), predicate vs novel regulatory pathways, and required evidence generation. The handbook emphasizes ISO 13485-aligned quality management systems, ISO 14971-based risk management, verification and validation planning, stability study expectations, and analytical/clinical performance evaluation design. It includes practical to‑do lists at each stage and consolidated checklists for MDR 2017 submissions (e.g., MD‑3/4/7/8/12/24/28), supporting smoother documentation readiness and regulatory submissions. The handbook is guidance and should be used alongside applicable statutory requirements.