Oxygen therapy apparatus

Oxygen therapy apparatus for therapeutic respiration

CDSCO CLEARANCE · CPCB CLEARANCE · +1 OTHER PGAS

HSN 9019 20 10 (Oxygen therapy apparatus) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as notified by the Ministry of Health and Family Welfare (MOHFW) vide G.S.R. 102(E) dated 11-02-2020. The Central Pollution Control Board (CPCB) Extended Producer Responsibility authorisation under the E-Waste (Management) Rules, 2022 applies as a concurrent overlay for importers of pulmonary ventilators and accessories, except micro-enterprises under the MSME Development Act, 2006.

What this is

HSN code

9019 20 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)

Customs documentation

Registration certificate from CDSCO
EPR authorisation from CPCB
Import compliance declaration from 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 oxygen therapy apparatus before filing the bill of entry. Import of medical devices listed in G.S.R. 102(E) dated 11-02-2020 is subject to compliance with the registration conditions specified therein; consignments without a current CDSCO registration are liable to detention and refusal of out-of-charge.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board before import, covering pulmonary ventilators and accessories as listed in Schedule I of the E-Waste (Management) Rules, 2022. The EPR obligation does not apply to micro-enterprises as defined under the MSME Development Act, 2006.
G.S.R. 801(E) dated 02-11-2022 · Schedule I, E-Waste (Management) Rules, 2022

A word of counsel

The most common error on this tariff line is treating the CDSCO registration as the sole clearance requirement and overlooking the CPCB EPR authorisation, which is an independent environmental-compliance obligation. An importer who holds a valid CDSCO registration but has not obtained EPR authorisation for pulmonary ventilators and accessories remains non-compliant at the bill-of-entry stage, exposing the consignment to detention under the E-Waste (Management) Rules, 2022 — the micro-enterprise exemption must be documented if claimed.

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Frequently asked

Does HSN 9019 20 10 require BIS certification?

No, oxygen therapy apparatus is not within the BIS Quality Control Order regime. Import is governed by Central Drugs Standard Control Organisation registration under the Medical Devices Rules, 2017, as notified by the Ministry of Health and Family Welfare vide G.S.R. 102(E) dated 11-02-2020, with a concurrent CPCB Extended Producer Responsibility overlay.

Which medical devices are covered by G.S.R. 102(E) dated 11-02-2020, and does CDSCO registration apply to foreign manufacturers?

G.S.R. 102(E) lists specific medical devices whose import is subject to CDSCO registration conditions; both the Indian importer and the foreign manufacturer must hold the requisite CDSCO registrations before the device is imported.

Does the EPR authorisation requirement apply to all importers of oxygen therapy apparatus?

The EPR authorisation under Schedule I of the E-Waste (Management) Rules, 2022 applies to importers of pulmonary ventilators and accessories — it is expressly excluded for micro-enterprises as defined under the MSME Development Act, 2006, but that exemption must be documented at the time of import.

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