CDSCO has issued a revised list of authorized laboratories for conducting performance evaluation of In-Vitro Diagnostic (IVD) kits across multiple disease categories, including HIV, HBV, HCV, TB, Dengue, and SARS-CoV-2. The update aims to strengthen regulatory compliance and streamline the evaluation process. Stakeholders are advised to align testing with approved labs prior to registration under MDR 2017.
Central Drugs Standard Control Organization (CDSCO) published an updated and expanded list of laboratories approved for performance evaluation of In-Vitro Diagnostic (IVD) medical devices. The list includes designated institutions for various diagnostic categories such as HIV, HBV, HCV, Dengue, Malaria, Tuberculosis, COVID-19, Cancer markers, and more. Authorized labs include facilities such as ICMR institutes, AIIMS campuses, and other government-recognized centers across India. The document also specifies the applicable technologies for evaluation (e.g., RT-PCR, ELISA, Rapid tests). This update supersedes previous versions and ensures a more standardized evaluation framework under MDR 2017. Manufacturers and importers are required to conduct evaluations only through these approved labs before submitting applications for registrations.