Spectrophotometers

Spectrophotometers using optical radiation (UV, visible, IR)

CDSCO CLEARANCE · CPCB CLEARANCE · +2 OTHER PGAS

HSN 9027 30 20 (Spectrophotometers) 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. Extended Producer Responsibility (EPR) authorisation under the E-Waste (Management) Rules, 2022 administered by the Central Pollution Control Board (CPCB) applies as a concurrent overlay, and imports of used or refurbished units face additional restrictions under the Ministry of Environment, Forest and Climate Change (MEFCC) Office Memorandum dated 15-12-2023.

What this is

HSN code

9027 30 20

Chapter

90 · Optical, photographic, measuring, checking, precision, medical or surgical instruments

Primary regulator

CDSCO · Medical Devices Rules, 2017 · G.S.R. 102(E) dated 11-02-2020

Customs documentation

Registration certificate from CDSCO
EPR authorisation from CPCB
Import compliance declaration from MOHFW

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

CPCBCPCB·Central Pollution Control Board

MOHFWMOHFW·Ministry of Health and Family Welfare

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Compliance steps

1
Obtain CDSCO registration for the spectrophotometer if it is listed in the medical-device notification G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare. All conditions specified in that notification — including importer registration and device registration with CDSCO — must be fulfilled before the bill of entry is filed.
G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017
2
Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board for import of analysers and accessories, as required under Schedule I of the E-Waste (Management) Rules, 2022. This obligation does not apply to micro enterprises as defined under the MSME Development Act, 2006.
E-Waste (Management) Rules, 2022 · G.S.R. 801(E) dated 02-11-2022
3
If importing used or refurbished spectrophotometers, comply with the additional conditions for high-end and high-value used medical equipment set out in the MEFCC Office Memorandum dated 15-12-2023. The import of such used equipment is Restricted and subject to conditions suggested by the Directorate General of Health Services.
MEFCC Office Memorandum dated 15-12-2023

A word of counsel

The most frequent error on this tariff line is treating the CDSCO medical-device registration and the CPCB EPR authorisation as alternatives rather than concurrent requirements — both must be satisfied independently before out-of-charge. For used or refurbished units, failure to identify the equipment as 'high-end and high-value' under the MEFCC O.M. dated 15-12-2023 before filing the bill of entry results in consignment detention, because the Restricted-import conditions for such goods are distinct from those governing new medical devices.

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Frequently asked

Does HSN 9027 30 20 require BIS certification?

No. No BIS Quality Control Order covers spectrophotometers under this tariff line. Import is governed by CDSCO registration under G.S.R. 102(E) dated 11-02-2020 and the Medical Devices Rules, 2017, with a concurrent CPCB Extended Producer Responsibility authorisation obligation under the E-Waste (Management) Rules, 2022.

Does the EPR authorisation requirement apply to all importers of spectrophotometers?

No. The EPR authorisation obligation under G.S.R. 801(E) dated 02-11-2022 does not apply to micro enterprises as defined in the MSME Development Act, 2006; all other importers of analysers and accessories falling under Schedule I of the E-Waste (Management) Rules, 2022 must hold a current EPR authorisation from CPCB.

Are used or refurbished spectrophotometers treated differently at import?

Yes. Import of high-end and high-value used or refurbished medical equipment is Restricted and subject to conditions set out in the MEFCC Office Memorandum dated 15-12-2023, which incorporates recommendations of the Directorate General of Health Services; these conditions are in addition to standard CDSCO registration requirements.

Last verified against gazette notifications: 2026-05-16. Source: CDSCO / CPCB / MOHFW / MEFCC / Indian Customs CUSDATA.