IVD CDSCO Registration

JR Compliance provides comprehensive regulatory support for In-Vitro Diagnostic (IVD) medical device registration under CDSCO guidelines and MDR 2017. Our experts assist with accurate device classification under Class A, B, C, or D categories based on risk assessment criteria. We help compile complete technical documentation including device master files, analytical performance data, and clinical evidence required for IVD approval. Our team manages the entire SUGAM portal submission process and handles all communication with CDSCO authorities throughout the review. We coordinate with notified bodies for conformity assessments and ensure your IVD devices meet all safety and performance requirements. Post-registration, we provide vigilance reporting support, license renewals, and ongoing regulatory compliance management for your IVD portfolio.