Portable X-ray machine

Portable X-ray machines for medical, surgical or veterinary uses

BIS QCO APPLICABLE · ISI MARK SCHEME · IS 7620 · CDSCO OVERLAY · CPCB OVERLAY · MEFCC OVERLAY · MOHFW OVERLAY

HSN 9022 14 20 (Portable X-ray machine) is covered by a Bureau of Indian Standards Quality Control Order. Conformity to IS 7620 (Part 1) is mandatory under the ISI Mark Scheme with effect from 16 April 2018, by virtue of DGFT Notification 03/2015-20. Atomic Energy Regulatory Board clearance, Central Drugs Standard Control Organisation registration, and Extended Producer Responsibility authorisation apply as separate customs-clearance overlays.

What this is

HSN code

9022 14 20

Chapter

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

BIS QCO

Applicable · ISI Mark Scheme · CM/L required

Indian Standard

IS 7620 (Part 1) · effective 16-04-2018

Applicable Partner Government Agencies

BISBIS·Bureau of Indian Standards

CDSCOCDSCO·Central Drugs Standard Control Organisation

CPCBCPCB·Central Pollution Control Board

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

MOHFWMOHFW·Ministry of Health and Family Welfare

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.

Compliance steps

1
Source only from a Bureau of Indian Standards CM/L-licensed manufacturer holding a current licence against IS 7620 (Part 1). Verify the supplier's CM/L number, licensed product scope, and licensed manufacturing facility on the BIS online register before placing the purchase order.
IS 7620 (Part 1) · DGFT Notification 03/2015-20 dated 16-04-2018 · ISI Mark Scheme under Scheme-I of the BIS (Conformity Assessment) Regulations, 2018
2
Obtain prior regulatory clearance from the Atomic Energy Regulatory Board before import. The Atomic Energy Act, 1962 and rules made thereunder mandate AERB clearance for all diagnostic X-ray equipment, independent of BIS QCO compliance.
Atomic Energy Act, 1962 · DGFT Notification 03/2015-20 dated 16-04-2018
3
Ensure the device is registered with the Central Drugs Standard Control Organisation under G.S.R. 102(E). Import of medical devices listed in G.S.R. 102(E) is subject to CDSCO registration and the conditions specified by the Ministry of Health and Family Welfare.
G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare
4
Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board before import. MSMED-registered micro enterprises are exempt. Upload the EPR authorisation and mandatory documents — certificate of analysis [0010DC], batch release certificate [0030DC], and label of consignment [0110DC] — in e-Sanchit before out-of-charge.
Schedule I of the E-Waste (Management) Rules, 2022 · G.S.R. 801(E) dated 02-11-2022
5
If the equipment is used or refurbished, verify admissibility against the Ministry of Environment, Forest and Climate Change Office Memorandum dated 15-12-2023 restricting import of high-end, high-value used medical equipment other than critical-care equipment. Quote the BIS CM/L number, AERB clearance, CDSCO registration, and EPR authorisation on the bill of entry.
O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023 · BIS Act, 2016 · Customs Act, 1962

A word of counsel

The single most common error on this tariff line is treating AERB clearance and CDSCO registration as the primary compliance obligations while leaving BIS CM/L verification as an afterthought. The ISI mark requirement under IS 7620 (Part 1) is a hard statutory precondition to import — a consignment arriving at port with valid AERB and CDSCO clearances but from a manufacturer without a current, in-scope CM/L licence faces detention under the BIS Act, 2016 regardless of the other clearances. The CM/L licence must cover the portable X-ray variant specifically; a licence scoped to stationary or non-portable equipment does not satisfy the obligation.

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Frequently asked

Does HSN 9022 14 20 require BIS certification?

Yes. Portable X-ray machines for medical, surgical, or veterinary uses must conform to IS 7620 (Part 1) under the ISI Mark Scheme with effect from 16 April 2018; import is permitted only from manufacturers holding a current BIS CM/L licence covering the portable variant.

Is AERB clearance required separately from BIS QCO compliance?

Yes. Prior regulatory clearance from the Atomic Energy Regulatory Board under the Atomic Energy Act, 1962 is mandatory and is independent of the BIS QCO obligation. Both must be satisfied before the consignment obtains out-of-charge.

Does the import restriction on used or refurbished medical equipment apply to portable X-ray machines?

Yes, unless the equipment qualifies as critical-care medical equipment per the Ministry of Environment, Forest and Climate Change Office Memorandum dated 15-12-2023. Used or refurbished portable X-ray machines outside that carve-out are restricted and subject to additional conditions.

Does a single CM/L licence cover both portable and stationary X-ray equipment from the same manufacturer?

No. The CM/L licence is scope-specific; a licence granted for stationary X-ray apparatus does not cover portable units. Customs verification against the BIS register is model- and product-scope-specific, and a mismatch triggers detention.

Last verified against gazette notifications: 2026-05-18. Source: BIS / CDSCO / CPCB / MOHFW / MEFCC / AERB / DGFT / Indian Customs CUSDATA.