CDSCO has released an updated, India‑wide list of authorized laboratories for performance evaluation of in‑vitro diagnostic (IVD) reagents and kits. The list maps specific disease categories - such as HIV, HBV, HCV, TB, dengue, influenza and SARS‑CoV‑2 - to designated government and ICMR/AIIMS facilities, along with nodal contacts. Manufacturers and importers must use these labs for evaluation under MDR 2017.
On 19 January 2026, CDSCO published an updated list of laboratories authorized to conduct performance evaluation of IVD medical devices across India.
The notification enumerates testing facilities - spanning NIB, multiple ICMR institutes, AIIMS campuses, VRDLs, and other government centers - mapped to 20+ IVD categories, including HIV, HBV, HCV, blood grouping, cancer markers, tuberculosis, malaria, dengue, chikungunya, syphilis, typhoid, influenza, toxoplasma, rubella/CMV, MRSA, enterovirus, congenital disorder markers, gonorrhoea, HPV typing, sickle cell, pneumonia and SARS‑CoV‑2. It also lists nodal officers and, where relevant, technologies (e.g., RT‑PCR, ELISA, rapid tests).
Stakeholders should route performance evaluations through these designated labs before regulatory submissions under the Medical Devices Rules, 2017