Refractometers
Optical refractometers for physical or chemical analysis
HSN 9027 50 20 (Refractometers) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules as notified 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 as a concurrent overlay. Import of used or refurbished high-value medical equipment is separately restricted under the Ministry of Environment, Forest and Climate Change (MEFCC) Office Memorandum dated 15-12-2023.
- Registration certificate from CDSCO
- EPR authorisation from CPCB
- Import declaration from MOHFW
- 1Obtain CDSCO registration for the refractometer as a medical device listed under G.S.R. 102(E) dated 11-02-2020. All conditions of registration — including Authorised Indian Representative appointment and foreign-manufacturer enrolment — must be fulfilled before the bill of entry is filed.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 under Schedule I of the E-Waste (Management) Rules, 2022, and upload it at the bill of entry. EPR authorisation is not required for importers qualifying as micro enterprises under the MSME Development Act, 2006.E-Waste (Management) Rules, 2022, Schedule I · G.S.R. 801(E) dated 02-11-2022
- 3If importing used or refurbished high-value refractometers other than critical care medical equipment, comply with the conditions set out in the MEFCC Office Memorandum dated 15-12-2023. This category is Restricted and requires documentation of compliance with those conditions before out-of-charge clearance.MEFCC Office Memorandum dated 15-12-2023
The most common error on this tariff line is satisfying the CDSCO registration requirement while overlooking the independent EPR authorisation obligation. EPR authorisation under the E-Waste (Management) Rules, 2022 applies to analysers and accessories regardless of the CDSCO clearance, and failure to hold a current EPR authorisation at the bill-of-entry stage constitutes a separate contravention attracting detention and monetary penalty — even where the device registration is in order. Micro enterprises should retain documentary evidence of their MSME status at port to invoke the EPR exemption.