Contact lenses
Contact lenses, unmounted optical contact elements
HSN 9001 30 00 (Contact lenses) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as contact lenses are listed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Import is contingent on compliance with all registration conditions specified in that notification, including CDSCO product registration and, where applicable, foreign-manufacturer registration.
- Registration certificate from CDSCO
- Import licence from CDSCO
- MOHFW notification compliance declaration
- 1Obtain CDSCO product registration for contact lenses as a listed medical device under G.S.R. 102(E) dated 11-02-2020. The registration must cover the specific device class and manufacturer; confirm that the foreign manufacturing facility holds the required CDSCO registration before filing the bill of entry.G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare · Medical Devices Rules, 2017
- 2Upload all mandatory CDSCO registration and import-licence documents in e-Sanchit at the bill of entry stage. Failure to present current and valid registration documentation results in consignment detention and ground rent liability at the port of import.G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017
The most common error on this tariff line is importing contact lenses under a distributor's or trader's CDSCO registration rather than a device-specific registration tied to the actual foreign manufacturer. CDSCO registration under the Medical Devices Rules, 2017 is manufacturer-specific and product-class-specific; a consignment bearing a registration certificate issued for a different manufacturer or device class is treated as an unregistered medical device, attracting seizure and potential criminal liability under the Drugs and Cosmetics Act, 1940.