Radiation beam delivery units

Radiation beam delivery units for radiotherapy

CDSCO CLEARANCE · CPCB CLEARANCE · +2 OTHER PGAS

HSN 9022 90 30 (Radiation beam delivery units) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as a medical device notified in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Prior regulatory clearance from the Atomic Energy Regulatory Board (AERB) under the Atomic Energy Act, 1962 and rules thereunder is also mandatory, per DGFT Notification 03/2015-20 dated 16-04-2018. Extended Producer Responsibility (EPR) authorisation from the Central Pollution Control Board (CPCB) under the E-Waste (Management) Rules, 2022 applies as an additional overlay for radiotherapy equipment and accessories.

What this is

HSN code

9022 90 30

Chapter

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

Primary regulator

CDSCO · Medical Devices Rules, 2017; AERB · Atomic Energy Act, 1962

Customs documentation

Registration certificate from CDSCO
Regulatory 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 radiation beam delivery unit as a medical device notified under G.S.R. 102(E) dated 11-02-2020. Before filing the bill of entry, upload in e-Sanchit the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc).
G.S.R. 102(E) dated 11-02-2020 (MOHFW) · Medical Devices Rules, 2017
2
Secure prior regulatory clearance from the Atomic Energy Regulatory Board under the Atomic Energy Act, 1962 and rules thereunder before the consignment is imported. Import of items under this tariff line is permitted only subject to this clearance; absence of AERB approval triggers detention at the bill-of-entry stage.
DGFT Notification 03/2015-20 dated 16-04-2018 · Atomic Energy Act, 1962
3
Verify and produce a valid Extended Producer Responsibility authorisation from the Central Pollution Control Board under Schedule I of the E-Waste (Management) Rules, 2022, covering radiotherapy equipment and accessories. The EPR obligation does not apply to micro-enterprises as defined under the MSMED 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 common error on this tariff line is obtaining CDSCO registration and treating import clearance as complete, without separately securing AERB prior regulatory approval. CDSCO registration and AERB clearance are independent gating requirements — a consignment with a current CDSCO registration but no AERB clearance will be detained at the port of entry, and no out-of-charge is available until both clearances are confirmed. EPR authorisation from CPCB is a further independent obligation and its absence attracts enforcement under the E-Waste (Management) Rules, 2022, regardless of the status of the CDSCO or AERB approvals.

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Frequently asked

Does HSN 9022 90 30 require BIS certification?

No, radiation beam delivery units are not covered by any BIS Quality Control Order. Import is governed by Central Drugs Standard Control Organisation registration under the Medical Devices Rules, 2017, with concurrent Atomic Energy Regulatory Board clearance under the Atomic Energy Act, 1962, and Extended Producer Responsibility authorisation from the Central Pollution Control Board 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 verified by the proper officer for PGA-facilitated bills.

Does the EPR authorisation requirement apply to all importers of radiation beam delivery units?

No. EPR authorisation from CPCB under Schedule I of the E-Waste (Management) Rules, 2022 is not applicable to micro-enterprises as defined under the MSMED Act, 2006; all other importers of radiotherapy equipment and accessories must hold a valid EPR authorisation per G.S.R. 801(E) dated 02-11-2022.

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