Other

Medical, surgical or laboratory sterilisers (other types)

CPCB CLEARANCE · PESO CLEARANCE

HSN 8419 20 90 (Other medical, surgical or laboratory sterilisers) is subject to Petroleum and Explosives Safety Organisation (PESO) import approval under the Gas Cylinders Rules, 2016 where the equipment involves pressure vessels, and to Central Pollution Control Board (CPCB) Extended Producer Responsibility (EPR) authorisation under the E-Waste (Management) Rules, 2022 for in-vitro diagnostic laboratory equipment and accessories. Central Board of Indirect Taxes and Customs (CBIC) policy overlays apply at the bill-of-entry stage.

What this is

HSN code

8419 20 90

Chapter

84 · Nuclear reactors, boilers, machinery and mechanical appliances; parts thereof

Primary regulator

CPCB · E-Waste (Management) Rules, 2022; PESO · Gas Cylinders Rules, 2016

Customs documentation

Import approval from PESO
EPR authorisation from CPCB
Third-party inspection certificate from manufacturer

Applicable Partner Government Agencies

CPCBCPCB·Central Pollution Control Board

PESOPESO·Petroleum and Explosives Safety Organisation

Procedural directions for customs clearance are issued by: Central Board of Indirect Taxes and Customs.

Compliance steps

1
Where the steriliser incorporates pressure vessels or cylinders (including oxygen cylinders), apply for PESO import approval through the PESO online system before shipment. The application must be supported by the manufacturer's ISO certificate, cylinder specifications and drawings, batch numbers, hydrostatic test certificate, and a third-party inspection certificate.
Gas Cylinders Rules, 2016 · CBIC Instruction 12/2021-Cus dated 25-05-2021 · Press Release ID 1718815 dated 15-05-2021 (Ministry of Commerce and Industry)
2
Verify whether Extended Producer Responsibility authorisation from the Central Pollution Control Board is required. EPR authorisation under Schedule I of the E-Waste (Management) Rules, 2022 applies to laboratory equipment used for in-vitro diagnosis and accessories — with the exception of all implanted and infected products — unless the importer qualifies as a micro enterprise under the MSMED Act, 2006.
E-Waste (Management) Rules, 2022, Schedule I · G.S.R. 801(E) dated 02-11-2022

A word of counsel

The EPR obligation under the E-Waste (Management) Rules, 2022 is triggered by the end-use of the equipment as in-vitro diagnostic laboratory apparatus, not by its tariff classification alone; importers who treat this as a pure capital-goods entry and overlook the CPCB authorisation face consignment detention and monetary penalty under the Environment (Protection) Act, 1986. The micro-enterprise exemption from EPR requires documentary proof of Udyam registration at the time of import — it cannot be claimed retrospectively after a customs query.

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Frequently asked

Does HSN 8419 20 90 require BIS certification?

No, no BIS Quality Control Order covers this tariff line. Import is governed by Petroleum and Explosives Safety Organisation approval under the Gas Cylinders Rules, 2016 (where pressure vessels are involved) and Central Pollution Control Board EPR authorisation under the E-Waste (Management) Rules, 2022 for in-vitro diagnostic laboratory equipment.

Does the PESO approval requirement apply to all sterilisers under this HSN, or only to those with pressure vessels?

PESO approval under the Gas Cylinders Rules, 2016 applies specifically where the equipment incorporates pressure vessels or cylinders for storage and transportation of gases such as medical oxygen; sterilisers without such components do not attract the PESO overlay.

Does the COVID-era PESO physical-inspection exemption for oxygen cylinders still govern current imports?

The press release dated 15 May 2021 and CBIC Instruction 12/2021-Cus established a temporary exemption from physical facility inspection for COVID relief imports; importers should confirm with PESO whether that relaxation remains operative, as the standard online-application procedure — including submission of ISO certificate, hydrostatic test certificate, and third-party inspection certificate — is the baseline requirement.

Last verified against gazette notifications: 2026-05-16. Source: CPCB / PESO / CBIC / Indian Customs CUSDATA.