The Central Drugs Standard Control Organisation (CDSCO) has directed its zonal and sub-zonal offices, along with State Licensing Authorities (SLAs), to maintain strict vigilance against the sale of unlicensed medical devices used in In Vitro Fertilisation (IVF) and Assisted Reproductive Technology (ART) procedures.

This move follows reports that certain firms are marketing and selling IVF-related devices—such as intrauterine insemination (IUI) kits and sperm-washing centrifuges—without obtaining the necessary approvals under the Medical Devices Rules, 2017.

In its communication, CDSCO reiterated that all medical devices are regulated under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. Licenses are mandatory for the import, manufacture, sale, and distribution of these devices, except for Class A non-sterile and non-measuring devices.

The regulator emphasized that devices used in IVF and ART procedures fall within the definition of medical devices and must comply with the prescribed regulatory framework.

Authorities have been instructed to ensure that no such devices are imported, manufactured, distributed, or sold without adhering to the applicable laws.

The directive comes at a time when IVF treatments are witnessing significant growth in India, alongside increasing regulatory oversight to standardize practices. According to Grant View Research, the country’s infertility treatment devices market, valued at USD 9.2 million in 2022, is projected to grow at a CAGR of 11.5 Percent, reaching USD 22 million by 2030.