Photometers
Photometers using optical radiations (UV, visible, IR)
HSN 9027 50 10 (Photometers) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, read with the Ministry of Health and Family Welfare (MOHFW) notification G.S.R. 102(E) dated 11-02-2020, where the device falls within the notified medical-device categories. The Central Pollution Control Board (CPCB) and Ministry of Environment, Forest and Climate Change (MEFCC) Extended Producer Responsibility (EPR) authorisation under the E-Waste (Management) Rules, 2022 applies as a concurrent overlay for importers of analyzers and accessories, except micro-enterprises as defined under the MSME Development Act, 2006.
- Registration certificate from CDSCO
- EPR authorisation from CPCB
- Import declaration from MOHFW
- 1Confirm whether the photometer falls within a notified medical-device category under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare. If so, obtain CDSCO registration prior to filing the bill of entry and ensure all conditions specified in that notification, including registration of the foreign manufacturer and importer, are satisfied.G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017
- 2Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board under Schedule I of the E-Waste (Management) Rules, 2022 before importing analyzers and accessories. This obligation applies to all importers except micro-enterprises as defined under the MSME Development Act, 2006; upload evidence of EPR authorisation in e-Sanchit at the bill of entry.E-Waste (Management) Rules, 2022, Schedule I · G.S.R. 801(E) dated 02-11-2022
- 3If the photometer is a used or refurbished high-end, high-value medical device (other than critical care equipment), comply with the additional conditions and Restricted-import regime applicable under the Office Memorandum issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023. Import of such equipment without satisfaction of these conditions is Restricted and may attract confiscation.O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023
The most common error on this tariff line is overlooking the dual-track regime: importers focus on CDSCO registration for the medical-device classification and neglect the EPR authorisation from CPCB, which applies independently to analyzers and accessories regardless of medical-device status. A consignment cleared by CDSCO but lacking a valid EPR authorisation remains non-compliant under the E-Waste (Management) Rules, 2022, and may attract detention and monetary penalty; the micro-enterprise exemption must be actively documented, not merely assumed.