This Guidance Document on Validation of Rapid Diagnostics for Pathogen Identification and Antimicrobial Susceptibility Testing (AST) – 2025, developed by the Indian Council of Medical Research (ICMR), provides a comprehensive framework for evaluating diagnostic tests. It outlines validation protocols, regulatory standards, and criteria for assessing accuracy, precision, and reproducibility. The document aims to standardize diagnostic validation, ensuring reliability and compliance with Medical Device Rules, 2017.
The Guidance Document on Validation of Rapid Diagnostics for Pathogen Identification and Antimicrobial Susceptibility Testing (AST) – 2025, published by the Indian Council of Medical Research (ICMR), provides a structured framework for validating in-vitro diagnostic (IVD) tests. It aligns with the Medical Device Rules, 2017, and regulatory guidelines set by the Central Drugs Standard Control Organization (CDSCO). The document details the validation process, regulatory approvals, and compliance requirements for diagnostic tests under the In-Vitro Diagnostic Medical Device (IVD MD) category. It outlines the ISO 20916:2019 and ISO 15189:2022 standards, emphasizing analytical and clinical performance evaluations. Additionally, it provides procedural guidance for obtaining regulatory approvals, including a Test License (MD-13), Clinical Performance Evaluation (MD-25), and Manufacturing License (MD-5/MD-6 or MD-9/MD-10). This guidance ensures diagnostic reliability, regulatory compliance, and clinical accuracy, benefiting innovators, manufacturers, and healthcare providers in developing robust diagnostic solutions for antimicrobial resistance (AMR). Key Points:
- Focus: Ensures diagnostic accuracy, reproducibility, and regulatory compliance.
- Target Beneficiaries: Innovators, manufacturers, and healthcare providers developing rapid diagnostics for antimicrobial resistance (AMR).