Other

Ionising radiation apparatus for medical, surgical or veterinary uses

CDSCO CLEARANCE · CPCB CLEARANCE · +1 OTHER PGAS

HSN 9022 14 90 covers other medical, surgical, and veterinary apparatus based on ionising radiations and 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). Central Pollution Control Board (CPCB) Extended Producer Responsibility authorisation under the E-Waste (Management) Rules, 2022 applies as a concurrent overlay for covered device categories including PET and radiotherapy equipment.

What this is

HSN code

9022 14 90

Chapter

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

Primary regulator

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

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

Compliance steps

1
Obtain CDSCO registration for the medical device under the conditions prescribed 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) · e-Sanchit document codes 0010dc, 0030dc, 0110dc
2
Verify whether the device falls within the EPR-covered categories under Schedule I of the E-Waste (Management) Rules, 2022 — specifically positron emission tomography (PET), radiotherapy equipment and accessories. If so, obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board before import; EPR does not apply to micro-enterprises as defined under the MSME Development Act, 2006.
E-Waste (Management) Rules, 2022, Schedule I · G.S.R. 801(E) dated 02-11-2022

A word of counsel

The most common error on this tariff line is assuming that CDSCO registration alone satisfies clearance and overlooking the CPCB EPR authorisation obligation for radiotherapy and PET equipment. EPR authorisation is an independent requirement routed through a separate PGA; a consignment arriving with a current CDSCO registration but no EPR authorisation for a Schedule I device will be detained at the port of entry pending CPCB compliance. Importers who qualify as micro-enterprises under the MSME Development Act, 2006 should retain documentary evidence of that status to assert the EPR exemption at the bill of entry stage.

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Frequently asked

Does HSN 9022 14 90 require BIS certification?

No, no BIS Quality Control Order covers this product family. Import is governed by Central Drugs Standard Control Organisation registration under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare, with a concurrent Central Pollution Control Board EPR authorisation requirement for covered device categories.

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). Out-of-charge will not be granted until all three are confirmed uploaded in e-Sanchit.

Does EPR authorisation apply to all ionising radiation medical devices under this HSN?

No. EPR authorisation under Schedule I of the E-Waste (Management) Rules, 2022 applies specifically to positron emission tomography (PET) equipment, radiotherapy equipment and accessories, with the exception of implanted and infected products; micro-enterprises as defined in the MSME Development Act, 2006 are exempt.

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