Calorimeters
Calorimeters for physical or chemical analysis
HSN 9027 89 20 (Calorimeters) 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 calorimeters fall within the notified medical device categories. Extended Producer Responsibility (EPR) authorisation from the Central Pollution Control Board (CPCB) under the E-Waste (Management) Rules, 2022 applies as an additional overlay, and import of used or refurbished high-value medical equipment is restricted under the Ministry of Environment, Forest and Climate Change (MEFCC) O.M. dated 15-12-2023.
- Registration certificate from CDSCO
- EPR authorisation from CPCB
- Import compliance declaration to MOHFW
- 1Verify that the calorimeter model is listed in the notified medical device schedule under G.S.R. 102(E) dated 11-02-2020 and obtain the requisite CDSCO registration before filing the bill of entry. All conditions specified in that notification, including registration of the foreign manufacturer and the Indian authorised representative, must be satisfied prior to import.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 for import of analyzers and accessories, in compliance with 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 of the E-Waste (Management) Rules, 2022
- 3Where the consignment consists of used or refurbished high-value medical equipment, confirm that the import satisfies the conditions set out in the MEFCC O.M. dated 15-12-2023, which restricts such imports. Critical care medical equipment is subject to a separate treatment under that O.M. and must be verified against the DGHS advisory.O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023
The most common error on this tariff line is importing used or refurbished calorimeters classified as high-end medical equipment without first establishing compliance with the MEFCC O.M. dated 15-12-2023; consignments that arrive at port without this clearance are detained as Restricted imports, and the customs officer cannot grant out-of-charge until the conditions of the O.M. are demonstrably satisfied. EPR authorisation is equally overlooked — the CPCB authorisation is a pre-import requirement, not a post-clearance obligation, and its absence independently grounds detention regardless of CDSCO registration status.