CDSCO has issued a circular advising all stakeholders to ensure that IVF media, reagents, cryopreservation products and related consumables regulated under the Medical Devices Rules, 2017 are supplied only to facilities registered under the Assisted Reproductive Technology (Regulation) Act, 2021 and Surrogacy (Regulation) Act, 2021, thereby safeguarding patient safety and ethical reproductive healthcare practices.
The Central Drugs Standard Control Organization (CDSCO) has informed stakeholders that media, reagents and consumables used in Assisted Reproductive Technology (ART) procedures such as In-Vitro Fertilization (IVF) and cryopreservation fall within the scope of the Medical Devices Rules, 2017 and therefore require appropriate manufacturing or import licences.
CDSCO noted that these products are intended for use by ART clinics and banks that are registered under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021. The authority has received information indicating that such products may be supplied to facilities that are not registered under these Acts, creating potential risks to patient safety and misuse of reproductive technology services. Stakeholders have consequently been requested to restrict supply to duly registered centres to ensure ethical, safe and regulated reproductive healthcare practices in India.