Spectrometers
Spectrometers using optical radiations (UV, visible, IR)
HSN 9027 30 10 (Spectrometers) 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), where the device falls within the notified medical-device schedule. Extended Producer Responsibility (EPR) authorisation under the E-Waste (Management) Rules, 2022 administered by the Central Pollution Control Board (CPCB) applies as a concurrent overlay, with import of used or refurbished high-value medical equipment subject to additional conditions under a Ministry of Environment, Forest and Climate Change (MEFCC) Office Memorandum dated 15-12-2023.
- Registration certificate from CDSCO
- EPR authorisation from CPCB
- Import compliance declaration from MOHFW
- 1Verify whether the spectrometer falls within the medical-device categories notified under G.S.R. 102(E) dated 11-02-2020. If it does, obtain CDSCO registration and ensure all conditions specified in that notification — including importer registration and authorised Indian representative requirements — are met before filing the bill of entry.G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare
- 2Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board covering analysers and accessories under Schedule I of the E-Waste (Management) Rules, 2022 before importation. The EPR obligation does not apply to micro-enterprises as defined under the MSME Development Act, 2006; retain proof of micro-enterprise status if claiming that exemption.E-Waste (Management) Rules, 2022, Schedule I · G.S.R. 801(E) dated 02-11-2022
- 3If importing used or refurbished high-value medical equipment (other than critical care medical equipment as categorised by DGHS), comply with the additional conditions stipulated in the MEFCC Office Memorandum dated 15-12-2023, under which such imports are Restricted.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 the CDSCO medical-device registration as the sole clearance requirement and overlooking the EPR authorisation from CPCB, which is an independent obligation triggered by the product's inclusion in Schedule I of the E-Waste (Management) Rules, 2022. A consignment may clear medical-device scrutiny at the bill of entry yet be detained for absence of EPR documentation; importers of used or refurbished units face a further restricted-import overlay under the MEFCC O.M. dated 15-12-2023 that applies regardless of CDSCO registration status.