For other uses
X-ray and ionising radiation apparatus for non-medical uses
HSN 9022 19 00 (apparatus based on ionising radiations for other uses) 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 from the Central Pollution Control Board (CPCB) under Schedule I of the E-Waste (Management) Rules, 2022 applies as a concurrent overlay, and import of used or refurbished high-value equipment is restricted under the Ministry of Environment, Forest and Climate Change (MEFCC) Office Memorandum dated 15-12-2023.
- Registration certificate from CDSCO
- EPR authorisation from CPCB
- Batch release certificate from CDSCO
- 1Ensure the medical device is registered with the Central Drugs Standard Control Organisation as required under G.S.R. 102(E) dated 11-02-2020. 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, Ministry of Health and Family Welfare · document codes 0010dc, 0030dc, 0110dc
- 2Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board for import of radiotherapy equipment and accessories — medical devices under Schedule I of the E-Waste (Management) Rules, 2022. EPR authorisation is not required for micro-enterprises as defined under the MSMED Act, 2006.G.S.R. 801(E) dated 02-11-2022 · Schedule I, E-Waste (Management) Rules, 2022
- 3If the consignment comprises used or refurbished high-end, high-value medical equipment other than critical care medical equipment, comply with all conditions in the MEFCC Office Memorandum dated 15-12-2023. This category is restricted and non-compliance renders the consignment liable to detention and re-export.O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023
The most common error on this tariff line is treating CDSCO device registration as the sole pre-import obligation and overlooking the EPR authorisation requirement from CPCB, which is independently verified at the bill-of-entry stage. A consignment with a current CDSCO registration but no EPR authorisation will be detained at the port of entry; the MSME micro-enterprise exemption from EPR must be documented with a valid Udyam registration — a bare assertion of micro-enterprise status is not accepted as compliance.