Gas or smoke analysis apparatus

Gas or smoke analysis apparatus (gas analyzers, smoke detectors)

CDSCO CLEARANCE · CPCB CLEARANCE · +2 OTHER PGAS

HSN 9027 10 00 (Gas or smoke analysis apparatus) 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 the apparatus is classified as a listed medical device. The Central Pollution Control Board (CPCB) Extended Producer Responsibility authorisation under the E-Waste (Management) Rules, 2022 applies as a concurrent obligation for importers of gas analyzers and accessories, and used or refurbished high-value medical equipment is subject to restricted-import conditions under the Ministry of Environment, Forest and Climate Change (MEFCC) O.M. dated 15-12-2023.

What this is

HSN code

9027 10 00

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, MOHFW)

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
Verify whether the specific gas or smoke analysis apparatus is listed under G.S.R. 102(E) dated 11-02-2020. Where listed, obtain CDSCO registration and ensure all conditions specified therein — including manufacturer registration and importer registration — are met before filing the bill of entry.
G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare notification · CDSCO registration conditions
2
Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board for import of gas analyzers and accessories. EPR authorisation is mandatory under Schedule I of the E-Waste (Management) Rules, 2022 and is exempt only 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
3
For import of high-end, high-value used or refurbished medical equipment other than critical care medical equipment, comply with the restricted-import conditions in the MEFCC O.M. dated 15-12-2023. Additionally, confirm whether the apparatus falls within the MTCTE mandatory-certification product list under Indian Telegraph (Amendment) Rules, 2017 and DoT Notifications including F.No.5-2/2024-TC/TEC(Pt.1) dated 25-02-2025.
MEFCC O.M. dated 15-12-2023 · DoT Notification F.No.5-2/2024-TC/TEC(Pt.1) dated 25-02-2025 · Indian Telegraph (Amendment) Rules, 2017

A word of counsel

The most common error on this tariff line is importing gas or smoke analysis apparatus under the assumption that only the CDSCO medical-device regime applies, while overlooking the CPCB EPR authorisation obligation. The EPR authorisation is an independent pre-import requirement under the E-Waste (Management) Rules, 2022 and non-compliance at the bill-of-entry stage results in consignment detention irrespective of CDSCO clearance; the micro-enterprise exemption is narrow and requires documented MSME status to invoke.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 9027 10 00 require BIS certification?

No, gas or smoke analysis apparatus is not covered by a BIS Quality Control Order. Import is governed by CDSCO registration under G.S.R. 102(E) dated 11-02-2020 where the apparatus qualifies as a listed medical device, alongside CPCB Extended Producer Responsibility authorisation under the E-Waste (Management) Rules, 2022.

Does the EPR authorisation requirement apply to all importers of gas analyzers?

Yes, with one narrow exception: micro-enterprises as defined under the MSME Development Act, 2006 are exempt. All other importers must hold a current CPCB EPR authorisation under Schedule I of the E-Waste (Management) Rules, 2022 per G.S.R. 801(E) dated 02-11-2022.

What additional restrictions apply to used or refurbished gas analysis equipment?

Import of high-end, high-value used or refurbished medical equipment — excluding critical care medical equipment — is restricted and subject to conditions specified in the MEFCC O.M. dated 15-12-2023; importers must verify compliance with those conditions before the purchase order is placed.

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