Licensure of In-Vitro Diagnostics (IVD) in India is governed by Medical Devices Rules 2017. One of the requirements under these rules is performance evaluation (validation) of IVDs to evaluate their quality and performance.

IVD validation is time consuming and since the COVID pandemic, there has been a surge in indigenous IVDs for multiple disease conditions, developed by several Indian manufacturers. Further, manufacturers of IVDs regularly approach the Indian Council of Medical Research (ICMR) with requests for validation of such kits. To strengthen the ecosystem of IVD validation in the country, ICMR in collaboration with CDSCO has developed standard IVD validation protocols. This portal will facilitate IVD validation across the country in a transparent and user-friendly way.