CDSCO Tightens Oversight on IVF Devices, Warns Against Unlicensed Sales

The Central Drugs Standard Control Organisation (CDSCO) has directed its zonal offices and State Licensing Authorities (SLAs) to enforce strict monitoring of medical devices used in In Vitro Fertilisation and other Assisted Reproductive Technology procedures. The move aims to prevent the sale of such devices without proper regulatory approval.

The directive follows reports that certain firms have been selling IVF-related devices—such as intrauterine insemination (IUI) kits and sperm-washing centrifuges—without obtaining licenses as required under the Medical Devices Rules, 2017 and the Drugs and Cosmetics Act, 1940.

CDSCO reiterated that all medical devices, except specific low-risk categories, must be licensed for import, manufacture, sale, and distribution. IVF-related equipment falls under regulated medical devices and must comply with these provisions.

The directive comes amid rapid growth in India’s fertility treatment market, with rising demand for IVF procedures and associated technologies driving increased regulatory scrutiny.

30-03-2026