Other
Other electromedical instruments and appliances for medical use
HSN 9018 19 90 (other electromedical instruments and appliances) 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). Central Pollution Control Board (CPCB) Extended Producer Responsibility (EPR) authorisation under the E-Waste (Management) Rules, 2022 applies as an additional overlay for fertilisation-test equipment and accessories. Importers of old or refurbished equipment must also comply with the conditions in CBIC Instruction 08/2024-Customs and Instruction 25/2024-Customs.
- Registration certificate from CDSCO
- EPR authorisation from CPCB
- Import permission from MOHFW
- 1Obtain CDSCO registration for the medical device prior to import. The device must appear in the notified list under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare, and registration must be valid at the time of filing the bill of entry. Non-registered devices are liable to detention and confiscation at the port.G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare notification
- 2Where the goods are fertilisation-test equipment or accessories (excluding implanted and infected products), verify that the importer holds a valid CPCB Extended Producer Responsibility authorisation under the E-Waste (Management) Rules, 2022. The EPR obligation does not apply to micro-enterprises as defined in the MSME Development Act, 2006.G.S.R. 801(E) dated 02-11-2022 · Schedule I of the E-Waste (Management) Rules, 2022
- 3For old or refurbished equipment, confirm that the specific model and category appears on the permitted list in CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024 before shipment. Import of old or refurbished devices not covered by either instruction will be refused clearance.CBIC Instruction 08/2024-Customs dated 05-04-2024 · CBIC Instruction 25/2024-Customs dated 28-10-2024
The most common error on this tariff line is assuming that a valid CDSCO registration alone secures clearance, while overlooking the EPR authorisation requirement for e-waste-generating sub-categories of electromedical equipment. Where the goods fall within Schedule I of the E-Waste (Management) Rules, 2022, the absence of CPCB EPR authorisation at the bill-of-entry stage triggers a separate ground for detention, independent of and additional to any CDSCO non-compliance — and the MSME exemption must be positively documented, not merely asserted.