X-ray valves

X-ray valves, parts and accessories for ionising radiation apparatus

CDSCO CLEARANCE · CPCB CLEARANCE · +2 OTHER PGAS

HSN 9022 90 10 (X-ray valves) 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), and to prior regulatory clearance from the Atomic Energy Regulatory Board (AERB) under the Atomic Energy Act, 1962 and rules thereunder. The Central Pollution Control Board (CPCB) Extended Producer Responsibility authorisation applies for radiotherapy equipment accessories under the E-Waste (Management) Rules, 2022, with the Directorate General of Foreign Trade (DGFT) administering the ITC (HS) policy overlay per DGFT Notification 03/2015-20 dated 16-04-2018.

What this is

HSN code

9022 90 10

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
AERB prior clearance from AERB
EPR authorisation from CPCB

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

CPCBCPCB·Central Pollution Control Board

MOHFWMOHFW·Ministry of Health and Family Welfare

AERBAERB·Atomic Energy Regulatory Board

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

Compliance steps

1
Obtain CDSCO registration for the medical device under the conditions specified in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare. Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit before filing the bill of entry.
G.S.R. 102(E) dated 11-02-2020 · MOHFW notification · CDSCO Medical Devices Rules, 2017
2
Obtain prior regulatory clearance from the Atomic Energy Regulatory Board before shipment. Import is permitted only subject to the Atomic Energy Act, 1962 and rules thereunder; consignments lacking AERB clearance are liable to detention and refusal of out-of-charge.
Atomic Energy Act, 1962 · DGFT Notification 03/2015-20 dated 16-04-2018
3
Verify whether an Extended Producer Responsibility authorisation from the Central Pollution Control Board is required under Schedule I of the E-Waste (Management) Rules, 2022. The EPR obligation applies to radiotherapy equipment and accessories (excluding all implanted and infected products) and is waived only for micro-enterprises as defined under the MSME Development Act, 2006.
G.S.R. 801(E) dated 02-11-2022 · Schedule I of the E-Waste (Management) Rules, 2022

A word of counsel

The most frequent compliance gap on this tariff line is securing CDSCO registration while overlooking the independent AERB prior-clearance requirement, which operates as a separate pre-import gate and cannot be regularised post-arrival. A consignment cleared by CDSCO but lacking AERB authorisation remains non-compliant and is subject to detention; the EPR authorisation from CPCB must also be in place at the bill-of-entry stage, not obtained retrospectively after out-of-charge.

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 9022 90 10 require BIS certification?

No. No BIS Quality Control Order covers X-ray valves or parts and accessories for ionising radiation apparatus. Import is governed by CDSCO registration under G.S.R. 102(E) dated 11-02-2020, prior clearance from the Atomic Energy Regulatory Board under the Atomic Energy Act, 1962, and CPCB Extended Producer Responsibility authorisation under the E-Waste (Management) Rules, 2022.

Which e-Sanchit document codes are mandatory at the bill of entry for this tariff line?

Three documents must be uploaded in e-Sanchit before out-of-charge: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc), as required for PGA-facilitated bills where the consignment has not been routed through the PGA for NOC.

Does the EPR authorisation requirement apply to all importers of X-ray valves?

No. The EPR authorisation under G.S.R. 801(E) dated 02-11-2022 applies to radiotherapy equipment and accessories but is expressly exempt for micro-enterprises as defined under the MSME Development Act, 2006, and does not apply to implanted or infected products.

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