India’s medical device regulator, the Central Drugs Standard Control Organization (CDSCO), in partnership with the Indian Council of Medical Research (ICMR), has issued draft standard evaluation protocols for assessing the quality and performance of In-Vitro Diagnostics (IVDs) for licensing under the Medical Devices Rules, 2017.
These protocols are intended for use by IVD manufacturers, testing laboratories, and the regulator itself. Stakeholders have been invited to submit feedback on the draft by August 25, 2025.
The 180-page draft outlines detailed performance and field evaluation methods for 15 categories of IVDs, including diagnostic kits for Influenza, SARS-CoV-2, Respiratory Syncytial Virus (RSV), Malaria, Nipah virus, Chandipura virus, and Dengue.
Under the draft, manufacturers and testing laboratories will be required to validate kits for analytical sensitivity, specificity, cross-reactivity, repeatability, and reproducibility against reference assays using characterized clinical sample panels. The protocols also cover multiplex detection kits capable of identifying multiple pathogens in a single test.
For respiratory viruses, the guidelines provide a framework for evaluating molecular assays such as real-time RT-PCR, LAMP, and cartridge-based platforms to ensure reliability in diagnosing seasonal Influenza A (H1N1, H3N2), Influenza B (Yamagata, Victoria), SARS-CoV-2, and RSV. The requirements include accredited evaluation laboratories, BSL-2 facilities, trained manpower, and participation in external quality assurance programs.
ICMR has clarified that ethical approval is not needed for using irreversibly de-identified clinical samples, provided a self-declaration is submitted to institutional authorities.
Stakeholders have been invited to submit their comments by August 25, 2025, to ivdevaluation@gmail.com in the prescribed format. Once finalized, the protocols will see minimal scope for change.