CDSCO Registration for Ophthalmic Medical Devices CDSCO registration for ophthalmic medical devices in India is mandatory under the Medical Devices Rules, 2017 (MDR 2017). All 144 ophthalmic devices — from spectacle lenses (Class A) to vitreous body prostheses (Class D) — must be registered before sale, import, or distribution. Indian [...]
Introduction CDSCO registration for ultrasound machines is mandatory under the Medical Devices Rules (MDR), 2017. Ultrasound machines fall under Class C or Class D depending on intended use. Importers file Form MD-14 and receive an MD-15 import license. Manufacturers of Class A/B file MD-3 for an MD-5 license; Class C/D [...]
Introduction The BIS QCO Amendment 2026 makes ISI Mark certification compulsory for cross recessed screws (pan head, countersunk head, raised countersunk head, and hex head variants) under relevant IS standards. Manufacturers must apply via the BIS Connect portal, pass lab testing, and clear a factory inspection. Importers must obtain a [...]