Other
Other physical or chemical analysis instruments and apparatus
HSN 9027 89 90 (Other instruments and apparatus for physical or chemical analysis) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, for devices listed in 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 the E-Waste (Management) Rules, 2022 applies to importers of analyzers and accessories, and import of used or refurbished high-value medical equipment is restricted under an O.M. issued by the Ministry of Environment, Forest and Climate Change (MoEFCC) dated 15-12-2023.
- Registration certificate from CDSCO
- EPR authorisation from CPCB
- Import compliance declaration from MOHFW
- 1Verify whether the specific instrument falls within the medical devices listed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare. If listed, obtain the requisite CDSCO registration and ensure all conditions of registration are met before filing the bill of entry.G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017
- 2Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board for import of analyzers and accessories under Schedule I of the E-Waste (Management) Rules, 2022. EPR authorisation is not required for micro-enterprises as defined under the MSME Development Act, 2006.G.S.R. 801(E) dated 02-11-2022 · Schedule I, E-Waste (Management) Rules, 2022
- 3If importing used or refurbished high-end, high-value medical equipment (other than critical care medical equipment), comply with the conditions and restrictions specified in the O.M. issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023. 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 failing to distinguish between the CDSCO registration obligation (triggered by the G.S.R. 102(E) medical-device listing) and the CPCB EPR authorisation (triggered by the product's classification as electronic equipment under the E-Waste Rules). Both obligations can apply simultaneously to the same import, and missing either at the bill-of-entry stage results in consignment detention and demurrage at port while the deficiency is remedied. Additionally, importers of used or refurbished equipment frequently overlook the MoEFCC O.M. restrictions, which are separate from and additional to the CDSCO and EPR frameworks.