The Central Drugs Standard Control Organization (CDSCO) on March 27, 2026, issued the notification regarding the 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 following has been stated namely: -
• All medical devices are regulated under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017, and generally require a license for import, manufacture, sale, and distribution (except Class A non-sterile/non-measuring devices).
• Devices used in In Vitro Fertilization (IVF) and Assisted Reproductive Technology (ART), such as IUI kits and centrifuges for sperm washing, are classified as medical devices.
• It has been observed that some firms are selling these devices without obtaining the required licenses.
• This practice is a violation of the regulatory provisions under the applicable laws.
• Authorities are instructed to maintain strict vigilance and ensure that such devices are not imported, manufactured, distributed, or sold without proper compliance and licensing.
[Notification No. MED-12012(18)/1/2026-eoffice]
