Auto claves

Medical, surgical or laboratory sterilising autoclaves

CPCB CLEARANCE · PESO CLEARANCE

HSN 8419 20 10 (Autoclaves) is subject to Petroleum and Explosives Safety Organisation (PESO) import approval under the Gas Cylinders Rules, 2016 for pressure-vessel configurations, and to Central Pollution Control Board (CPCB) Extended Producer Responsibility authorisation under the E-Waste (Management) Rules, 2022 for laboratory-equipment variants within Schedule I. Central Board of Indirect Taxes and Customs (CBIC) policy overlays apply at the bill-of-entry stage.

What this is

HSN code

8419 20 10

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
Apply for PESO import approval through the PESO online system before the consignment is dispatched. The application must include the manufacturer's particulars, ISO certificate, list of cylinders with specifications, drawings and batch numbers, hydro-test certificate, and a third-party inspection certificate. PESO grants approval online on submission of these documents.
Gas Cylinders Rules, 2016 · CBIC Instruction 12/2021-Cus dated 25-05-2021 · DPIIT Press Release dated 15-05-2021 (Release ID 1718815)
2
Verify whether the importer is required to hold Extended Producer Responsibility authorisation from the Central Pollution Control Board under Schedule I of the E-Waste (Management) Rules, 2022. EPR authorisation is required for laboratory equipment for in vitro diagnosis and accessories — with the exception of all implanted and infected products — and is exempt only for micro-enterprises as defined under the MSME Development Act, 2006.
E-Waste (Management) Rules, 2022, Schedule I · G.S.R. 801(E) dated 02-11-2022

A word of counsel

The most common error on this tariff line is conflating the temporary COVID-era PESO inspection-waiver with a permanent exemption from import approval. The CBIC Instruction 12/2021-Cus relaxation was specific to oxygen cylinders imported for COVID relief; autoclaves and pressure vessels for other end-uses require the standard PESO online approval before customs out-of-charge is granted. Filing a bill of entry without a current PESO approval — or without EPR authorisation where the laboratory-equipment Schedule I category applies — exposes the consignment to detention and demurrage pending regularisation.

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Frequently asked

Does HSN 8419 20 10 require BIS certification?

No, no BIS Quality Control Order covers this tariff line. Import of autoclaves is governed by Petroleum and Explosives Safety Organisation approval under the Gas Cylinders Rules, 2016 for pressure-vessel configurations, and by Central Pollution Control Board Extended Producer Responsibility authorisation under the E-Waste (Management) Rules, 2022 for qualifying laboratory-equipment variants.

Does the PESO online-approval exemption granted during COVID-19 still apply to all autoclaves?

No. The relaxation under CBIC Instruction 12/2021-Cus dated 25-05-2021 and the DPIIT Press Release dated 15-05-2021 was limited to cylinders and pressure vessels for storage and transportation of medical oxygen imported for COVID relief; the standard PESO online-approval process under the Gas Cylinders Rules, 2016 applies to all other imports under this tariff line.

Which autoclaves are exempt from CPCB Extended Producer Responsibility authorisation?

EPR authorisation under Schedule I of the E-Waste (Management) Rules, 2022 does not apply to implanted and infected products, and is also exempt for micro-enterprises as defined under the MSME Development Act, 2006; all other importers of laboratory equipment for in vitro diagnosis and accessories must hold current CPCB EPR authorisation.

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