X-ray tubes
X-ray tubes for medical, surgical, dental or veterinary apparatus
HSN 9022 30 00 (X-ray tubes) 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 (EPR) authorisation from the Central Pollution Control Board (CPCB) applies under the E-Waste (Management) Rules, 2022, and the ITC (HS) import policy administered by the Directorate General of Foreign Trade (DGFT) conditions import on compliance with the Atomic Energy Act, 1962.
- Registration certificate from CDSCO
- Regulatory 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 X-ray tube as a medical device listed under G.S.R. 102(E) dated 11-02-2020 and ensure mandatory e-Sanchit uploads — Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) — are in place before out-of-charge.G.S.R. 102(E) dated 11-02-2020 (MOHFW) · CDSCO Medical Devices Rules, 2017
- 2Secure prior regulatory clearance from the Atomic Energy Regulatory Board before filing the bill of entry. The ITC (HS) import policy conditions import of this tariff line on full compliance with the Atomic Energy Act, 1962 and all rules thereunder.DGFT Notification 03/2015-20 dated 16-04-2018 · Atomic Energy Act, 1962
- 3Verify Extended Producer Responsibility authorisation from the Central Pollution Control Board under Schedule I of the E-Waste (Management) Rules, 2022, unless the importer qualifies as a micro-enterprise under the MSME Development Act, 2006, in which case the EPR obligation does not apply.G.S.R. 801(E) dated 02-11-2022 · Schedule I, E-Waste (Management) Rules, 2022
The most common error on this tariff line is securing CDSCO registration and treating clearance as complete, while overlooking the independent AERB prior-clearance requirement. AERB clearance is not subsumed by the CDSCO registration — both are mandatory preconditions, and a consignment arriving without AERB clearance will be detained at port regardless of the currency of the CDSCO registration. The EPR authorisation from CPCB is a separate pre-import obligation and the micro-enterprise exemption must be documented at the time of filing, not claimed retrospectively.