Artificial kidney (dialysis) apparatus

Artificial kidney dialysis apparatus (dialysis machines)

CDSCO CLEARANCE · CPCB CLEARANCE · +1 OTHER PGAS

HSN 9018 90 31 (Artificial kidney dialysis apparatus) 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 as a concurrent obligation, except for micro-enterprises under the MSMED Act, 2006.

What this is

HSN code

9018 90 31

Chapter

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

Primary regulator

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

Customs documentation

Registration certificate from CDSCO
EPR authorisation from CPCB
Import compliance declaration to MOHFW

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 dialysis apparatus in compliance with all conditions specified in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare. The registration must be current at the time of filing the bill of entry; consignments from unregistered manufacturers or importers are liable to detention and confiscation.
G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare
2
Secure Extended Producer Responsibility authorisation from the Central Pollution Control Board under Schedule I of the E-Waste (Management) Rules, 2022 before import. EPR authorisation is mandatory for dialysis equipment and accessories — with the exception of all implanted and infected products — and is exempt only 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 importing in old or refurbished condition, verify that the specific equipment model appears on the permitted list issued under CBIC Instruction 08/2024-Customs dated 05-04-2024 and CBIC Instruction 25/2024-Customs dated 28-10-2024. Refurbished dialysis apparatus not on the permitted list is not eligible for import and is subject to re-export or confiscation.
CBIC Instruction 08/2024-Customs dated 05-04-2024 · CBIC Instruction 25/2024-Customs dated 28-10-2024

A word of counsel

The most common error on this tariff line is treating CDSCO registration as the sole clearance requirement and overlooking the EPR authorisation from CPCB — these are independent obligations operating under separate legal instruments, and the absence of EPR authorisation at the bill-of-entry stage will trigger detention even when CDSCO registration is valid and current. Importers of refurbished units face a further trap: the permissible-equipment list under Instructions 08/2024-Customs and 25/2024-Customs is exhaustive, and a dialysis machine absent from that list cannot be regularised post-arrival.

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Frequently asked

Does HSN 9018 90 31 require BIS certification?

No, artificial kidney dialysis apparatus is not covered by any BIS Quality Control Order. Import is governed by Central Drugs Standard Control Organisation registration under G.S.R. 102(E) dated 11-02-2020, with a concurrent Extended Producer Responsibility authorisation requirement under the E-Waste (Management) Rules, 2022 administered by CPCB.

Does the EPR authorisation requirement apply to all importers of dialysis equipment?

No. EPR authorisation under G.S.R. 801(E) dated 02-11-2022 is exempt for micro-enterprises as defined in the MSMED Act, 2006; all other importers of dialysis equipment and accessories — excluding implanted and infected products — must hold a valid CPCB EPR authorisation before import.

Can second-hand or refurbished dialysis machines be imported under this tariff line?

Only if the specific equipment model is listed in the permitted-import schedules under CBIC Instruction 08/2024-Customs dated 05-04-2024 and CBIC Instruction 25/2024-Customs dated 28-10-2024; refurbished units not appearing on those lists are ineligible for import and face re-export or confiscation.

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