Linear ultrasound scanner
Linear ultrasound scanner for medical imaging
HSN 9018 12 10 (Linear ultrasound scanner) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Extended Producer Responsibility (EPR) authorisation under the E-Waste (Management) Rules, 2022 applies as a concurrent requirement administered by the Central Pollution Control Board (CPCB). Import of used or refurbished units is separately restricted under the Office Memorandum issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023.
- Registration certificate from CDSCO
- EPR authorisation from CPCB
- Import permit from CDSCO
- 1Obtain CDSCO registration for the linear ultrasound scanner as a listed medical device under G.S.R. 102(E) dated 11-02-2020. Confirm that all conditions stipulated in that notification — including manufacturer registration and Authorised Indian Representative appointment — are met before the bill of entry is filed.G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare
- 2Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board before importation of ultrasound imaging equipment. EPR authorisation is mandated under Schedule I of the E-Waste (Management) Rules, 2022 per G.S.R. 801(E) dated 02-11-2022; the obligation does not apply to micro enterprises as defined under the MSME Development Act, 2006.G.S.R. 801(E) dated 02-11-2022 · Schedule I, E-Waste (Management) Rules, 2022
- 3For import of used or refurbished linear ultrasound scanners, verify whether the specific equipment is included in the permitted list under CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024. High-end and high-value used medical equipment not falling within that permitted list is Restricted and subject to the conditions of the Ministry of Environment, Forest and Climate Change O.M. dated 15-12-2023.CBIC Instruction 08/2024-Customs dated 05-04-2024 · CBIC Instruction 25/2024-Customs dated 28-10-2024 · O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023
The most common error on this tariff line is clearing a used or refurbished unit as if it were new equipment: the CDSCO registration is necessary for both new and refurbished devices, but the used-equipment restriction layer under CBIC Instructions 08/2024-Customs and 25/2024-Customs operates independently and supersedes the registration clearance. A consignment with a current CDSCO registration that has not been confirmed against the permitted old/refurbished equipment list remains Restricted at the bill-of-entry stage, and detention at the port of import — with attendant demurrage — is the operative outcome.