For medical, surgical, dental or veterinary uses

X-ray apparatus for medical, surgical, dental or veterinary uses

CDSCO CLEARANCE · CPCB CLEARANCE · +2 OTHER PGAS

HSN 9022 21 00 (X-ray and ionising-radiation apparatus for medical, surgical, dental or veterinary uses) 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). Extended Producer Responsibility (EPR) authorisation from the Central Pollution Control Board (CPCB) under the E-Waste (Management) Rules, 2022 applies concurrently for PET and radiotherapy equipment. Import of used or refurbished high-end medical equipment is separately restricted under the Ministry of Environment, Forest and Climate Change (MEFCC) O.M. dated 15-12-2023.

What this is

HSN code

9022 21 00

Chapter

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

Primary regulator

CDSCO · Medical Devices Rules, 2017 read with G.S.R. 102(E) dated 11-02-2020

Customs documentation

Registration certificate from CDSCO
EPR authorisation from CPCB
Batch release certificate from CDSCO

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

CPCBCPCB·Central Pollution Control Board

MOHFWMOHFW·Ministry of Health and Family Welfare

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Compliance steps

1
Obtain CDSCO registration for the medical device under the conditions prescribed in G.S.R. 102(E) dated 11-02-2020. 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 the bill of entry is filed.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · document codes 0010dc, 0030dc, 0110dc
2
For import of positron emission tomography (PET) equipment, radiotherapy equipment, and medical device accessories listed in Schedule I of the E-Waste (Management) Rules, 2022, obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board. EPR authorisation is not required for 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
3
If the consignment comprises used or refurbished high-end, high-value medical equipment (other than critical care equipment as identified by DGHS), comply with the Restricted-import conditions prescribed in the Ministry of Environment, Forest and Climate Change O.M. dated 15-12-2023. Non-compliance renders such consignments liable to detention and re-export.
O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023

A word of counsel

The most frequent error on this tariff line is overlooking the EPR authorisation requirement as a parallel, independent obligation from the CDSCO registration — importers who hold a current CDSCO registration for radiotherapy or PET equipment and assume no further environmental compliance is needed face consignment detention pending CPCB EPR verification. Additionally, the used-equipment restriction under the MEFCC O.M. of 15-12-2023 applies regardless of whether CDSCO registration is in order; both regimes must be satisfied before out-of-charge.

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Frequently asked

Does HSN 9022 21 00 require BIS certification?

No, no BIS Quality Control Order covers medical X-ray and ionising-radiation apparatus. Import is governed by Central Drugs Standard Control Organisation registration under G.S.R. 102(E) dated 11-02-2020, with concurrent EPR authorisation from the Central Pollution Control Board for PET and radiotherapy equipment under the E-Waste (Management) Rules, 2022.

Which document codes must be uploaded in e-Sanchit for this tariff line?

Three documents are mandatory at the bill of entry: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc); all must be uploaded in e-Sanchit before customs out-of-charge is granted.

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

EPR authorisation under G.S.R. 801(E) applies to PET, radiotherapy equipment, and accessories listed in Schedule I of the E-Waste (Management) Rules, 2022, but is explicitly exempt for micro-enterprises as defined in the MSMED Act, 2006.

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