CDSCO Orders Strict Regulation of IVF, ART Medical Devices, Bars Unlicensed Sale

New Delhi: Through a recent notice, the Central Drugs Standard Control Organization (CDSCO) has directed strict regulatory oversight on the import, manufacture, sale, and distribution of medical devices used in In Vitro Fertilization (IVF) and Assisted Reproductive Technology (ART) procedures.

The directive highlights that all medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017, and require appropriate licensing for import, manufacturing, sale, and distribution, except for Class A non-sterile and non-measuring medical devices.

It further clarifies that devices used in IVF procedures—including IUI (Intrauterine Insemination) kits and centrifuges for sperm washing—fall within the definition of medical devices under the existing regulatory framework.

The CDSCO has taken note of instances where firms are selling medical devices intended for In Vitro Fertilization viz., IUI (Intrauterine Insemination) kits, centrifuges for sperm washing, etc., used for Assisted Reproductive Technology related procedures without obtaining license from the licensing authority under the Medical Devices Rules, 2017.

In response, the apex drug regulator has instructed all State and Union Territory drug control and licensing authorities to maintain strict vigilance and ensure that no such devices are imported, manufactured, distributed, or sold without compliance with the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017.

The notice concluded by directing all State/UT Drugs Control and Licensing Authorities, Zonal, Sub-Zonal and Port Offices of the Central Drugs Standard Control Organization (CDSCO), as well as stakeholders through its official website, stating,

"You are requested to keep strict vigil & ensure that no such devices used for In Vitro Fertilization for Assisted Reproductive Technology related procedures are being imported, manufactured, distributed, sold without bidance to the Drugs and Cosmetics Act,1940 and Medical Devices Rules, 2017."

The circular has been addressed to all State/UT Drugs Control and Licensing Authorities, along with all Zonal, Sub-Zonal, and Port Offices of CDSCO. It has also been shared with stakeholders via the CDSCO website for wider awareness and compliance.

To view the official notice, click the link below: