Introduction CDSCO medical device registration hospital beds in India is mandatory under the Medical Devices Rules, 2017. Hospital beds are classified as Class A, B, C, or D depending on risk. Importers apply via Form MD-14 and receive a grant through MD-15. Domestic manufacturers use Form MD-3 (Class A/B, licensed [...]
Introduction Patient monitors are notified medical devices under the Medical Devices Rules, 2017. They fall under Class A, B, C, or D depending on risk level. Importers need CDSCO licenses via Form MD-14 (application) and MD-15 (license grant). Manufacturers require MD-3/MD-5 for Class A & B and MD-7/MD-9 for Class [...]
CDSCO K-Beauty product registration follows two separate pathways depending on whether the products are imported or manufactured in India. For imported Korean cosmetics, the Indian agent, subsidiary, or importer files Form COS-1 on the CDSCO SUGAM portal; once CDSCO reviews the formulation, labelling, and Free Sale Certificate, it issues the [...]