Chromatographs and electrophoresis instruments
Chromatographs and electrophoresis instruments for chemical analysis
HSN 9027 20 00 (Chromatographs and electrophoresis instruments) 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 instrument is a notified medical device. Extended Producer Responsibility (EPR) authorisation under the E-Waste (Management) Rules, 2022 administered by the Central Pollution Control Board (CPCB) applies concurrently, and imports of used or refurbished high-value medical equipment are Restricted under the Ministry of Environment, Forest and Climate Change (MEFCC) O.M. dated 15-12-2023.
- Device registration certificate from CDSCO
- EPR authorisation from CPCB
- Restricted-import compliance from MEFCC
- 1Verify whether the chromatograph or electrophoresis instrument is listed in the notified medical devices schedule under G.S.R. 102(E) dated 11-02-2020. If listed, obtain CDSCO registration before filing the bill of entry and upload the registration certificate in e-Sanchit; import without a valid CDSCO registration is non-compliant and attracts detention.G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare
- 2Obtain EPR authorisation from the Central Pollution Control Board covering analyzers and accessories under Schedule I of the E-Waste (Management) Rules, 2022 before import. The EPR obligation does not apply to micro-enterprises as defined under the MSME Development Act, 2006; maintain documentary evidence of micro-enterprise status if claiming exemption.G.S.R. 801(E) dated 02-11-2022 · Schedule I of the E-Waste (Management) Rules, 2022
- 3If importing used or refurbished high-end, high-value medical equipment that is not critical care equipment, comply with the conditions specified in the MEFCC O.M. dated 15-12-2023 as suggested by the Directorate General of Health Services. Such imports are Restricted and require satisfaction of the conditions enumerated in that O.M. before out-of-charge.O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023
The most common error on this tariff line is assuming that the EPR and CDSCO obligations are mutually exclusive — that a laboratory-grade chromatograph not classified as a medical device escapes both regimes. In practice, CPCB EPR authorisation under the E-Waste (Management) Rules, 2022 attaches to analyzers and accessories regardless of medical-device classification, so an instrument that sits outside G.S.R. 102(E) still requires EPR authorisation; failure to hold it at the bill-of-entry stage results in consignment detention and demurrage.