X-ray generators and apparatus (non-portable)

Non-portable X-ray generators and apparatus 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 10 (non-portable X-ray generators and apparatus for medical, surgical or veterinary uses) 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, pursuant to DGFT Notification 03/2015-20. Central Drugs Standard Control Organisation registration under G.S.R. 102(E), Atomic Energy Regulatory Board clearance, and Extended Producer Responsibility authorisation each apply as separate customs-clearance overlays.

What this is

HSN code

9022 14 10

Chapter

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

BIS QCO

Applicable · ISI Mark Scheme · CM/L required

Indian Standard

IS 7620 · 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
Verify the foreign manufacturer's BIS CM/L licence against IS 7620 (Part 1) on the BIS online register before placing the purchase order. Confirm the licensed scope covers the specific X-ray generator model, output rating, and manufacturing facility address.
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. Diagnostic medical X-ray equipment is subject to the Atomic Energy Act, 1962 and the rules framed thereunder; AERB clearance is a pre-import condition independent of BIS 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 the conditions specified in G.S.R. 102(E). Medical devices listed in that gazette notification must comply with all registration conditions before clearance from customs.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare
4
Upload all mandatory documents — Certificate of Analysis (document code 0010DC), Batch Release Certificate (0030DC), and Label of Consignment (0110DC) — on e-Sanchit before the out-of-charge order is issued. Customs officers verify these documents for PGA-facilitated bills not routed through the PGA for a No Objection Certificate.
ITC (HS) import policy · e-Sanchit document upload requirement
5
Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board under the E-Waste (Management) Rules, 2022 before import. Micro enterprises as defined in the MSME Development Act, 2006 are exempt. Quote the EPR authorisation number on the bill of entry.
Schedule I of the E-Waste (Management) Rules, 2022 · G.S.R. 801(E) dated 02-11-2022

A word of counsel

The most common oversight on this tariff line is treating BIS CM/L compliance as the sole pre-import gateway while allowing Atomic Energy Regulatory Board clearance to be sought in parallel or after shipment. AERB clearance is a statutory pre-import condition under the Atomic Energy Act, 1962; a consignment without it cannot lawfully enter India regardless of a valid CM/L licence, and port detention accrues demurrage and ground rent from arrival date. Initiate AERB clearance before the purchase order, not after the bill of lading is issued.

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Frequently asked

Does HSN 9022 14 10 require BIS certification?

Yes. Non-portable X-ray generators and apparatus for medical, surgical or veterinary uses must conform to IS 7620 (Part 1) under the ISI Mark Scheme, mandatory with effect from 16 April 2018 pursuant to DGFT Notification 03/2015-20; import is permitted only from manufacturers holding a current BIS CM/L licence.

Is AERB clearance required separately from BIS QCO compliance?

Yes. Atomic Energy Regulatory Board clearance is a mandatory pre-import condition under the Atomic Energy Act, 1962 and is entirely independent of the BIS CM/L obligation; both must be satisfied before customs out-of-charge.

Are used or refurbished X-ray generators permitted for import?

Import of high-end and high-value used or refurbished medical equipment is restricted and subject to conditions per the Office Memorandum issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023; critical care medical equipment is treated separately under that framework.

Does a single CM/L licence cover all models and manufacturing facilities of the same supplier?

No. A CM/L licence is scope-specific by model, output specification, and manufacturing facility; X-ray generators outside the licensed model range or produced at an unlicensed plant are not covered, and customs detains the consignment on a scope mismatch.

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