Radiation generation units
Radiation generation units for ionising radiation apparatus
HSN 9022 90 20 (Radiation generation units) is subject to the Atomic Energy Regulatory Board (AERB) prior regulatory clearance under the Atomic Energy Act, 1962 and rules thereunder, as a condition of import. 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) applies as a concurrent medical-device overlay, and Extended Producer Responsibility authorisation from the Central Pollution Control Board (CPCB) is required under the E-Waste (Management) Rules, 2022.
- Prior regulatory clearance from AERB
- Registration certificate from CDSCO
- EPR authorisation from CPCB
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.
- 1Obtain prior regulatory clearance from the Atomic Energy Regulatory Board before shipment. Import of radiation generation units is permitted only subject to the Atomic Energy Act, 1962 and its rules; consignments without AERB clearance are liable to detention and confiscation at the port of entry.Atomic Energy Act, 1962 · DGFT Notification 03/2015-20 dated 16-04-2018
- 2Ensure the medical device is registered with the Central Drugs Standard Control Organisation under the conditions of G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare, and upload mandatory e-Sanchit documents: Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) before out-of-charge.G.S.R. 102(E) dated 11-02-2020 · CDSCO Medical Devices Rules, 2017
- 3Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board for import of radiotherapy equipment and accessories, as required under Schedule I of the E-Waste (Management) Rules, 2022. The EPR requirement does not apply to micro-enterprises as defined under the MSME Development Act, 2006.E-Waste (Management) Rules, 2022, Schedule I · G.S.R. 801(E) dated 02-11-2022
The most common error on this tariff line is securing CDSCO registration and assuming that satisfies all pre-import obligations — the AERB prior regulatory clearance is a separate, independent requirement under the Atomic Energy Act, 1962, and customs officers are instructed to verify both before granting out-of-charge. Missing AERB clearance will result in consignment detention regardless of the currency of the CDSCO registration, and retrospective AERB approval is not available at the bill-of-entry stage.