Computed tomography apparatus
Computed tomography apparatus (CT scanners)
HSN 9022 12 00 (Computed tomography apparatus) 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), and to prior regulatory clearance from the Atomic Energy Regulatory Board (AERB) under the Atomic Energy Act, 1962. Extended Producer Responsibility authorisation from the Central Pollution Control Board (CPCB) under the E-Waste (Management) Rules, 2022 applies concurrently, and import of used or refurbished high-value equipment carries additional DGFT-policy restrictions.
- Registration certificate from CDSCO
- Prior clearance from AERB
- EPR authorisation from CPCB
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.
- 1Obtain CDSCO registration for the CT apparatus under G.S.R. 102(E) dated 11-02-2020, issued by the Ministry of Health and Family Welfare. Upload the certificate of analysis (document code 0010dc), batch release certificate (document code 0030dc), and label of consignment (document code 0110dc) in e-Sanchit before filing the bill of entry.G.S.R. 102(E) dated 11-02-2020 (MOHFW) · CDSCO registration requirement · e-Sanchit document codes 0010dc, 0030dc, 0110dc
- 2Secure prior regulatory clearance from the Atomic Energy Regulatory Board before shipment. This clearance is mandated under the Atomic Energy Act, 1962 and rules thereunder, as incorporated into the ITC (HS) import policy condition via DGFT Notification 03/2015-20 dated 16-04-2018.Atomic Energy Act, 1962 · DGFT Notification 03/2015-20 dated 16-04-2018
- 3Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board under Schedule I of the E-Waste (Management) Rules, 2022. The EPR obligation applies to CT scanners and radiotherapy equipment unless the importer qualifies as a micro enterprise under the MSME Development Act, 2006. Import of used or refurbished high-value CT equipment is Restricted and subject to conditions in the O.M. issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023.G.S.R. 801(E) dated 02-11-2022 · Schedule I of the E-Waste (Management) Rules, 2022 · O.M. of MEFCC dated 15-12-2023
The most common error on this tariff line is treating CDSCO registration as the sole pre-import requirement and overlooking the AERB prior clearance, which is a separate and independent obligation under the Atomic Energy Act, 1962. A consignment arriving without AERB clearance — even where CDSCO registration is current and e-Sanchit uploads are complete — will be detained at port, and no out-of-charge can be granted until the AERB clearance is produced. Importers of used or refurbished CT equipment must additionally confirm they are not within the MEFCC O.M. dated 15-12-2023 restriction on high-end, high-value equipment before contracting the purchase.