Import, manufacturing, sale etc. of medical devices intended for InVitro Fertilization viz., IUI (Intrauterine Insemination) kits, centrifuge for sperm washing etc. used for Assisted Reproductive Technology related procedures

The circular issued by CDSCO states that medical devices intended for IVF and assisted reproductive technology procedures, such as IUI (Intrauterine Insemination) kits and centrifuges for sperm washing, are regulated medical devices under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017. It clarifies that licensing is mandatory for import, manufacture, sale and distribution in India, except for Class A non-sterile and non-measuring devices where applicable. CDSCO has observed that some firms are selling these products without obtaining the required licence from the licensing authority. The circular instructs all state and union territory drug control authorities and relevant stakeholders to maintain strict vigilance and ensure that such devices are not imported, manufactured, distributed, or sold without due compliance with the applicable regulatory framework.