Other

Therapeutic respiration apparatus other than ventilators

CDSCO CLEARANCE · CPCB CLEARANCE · +1 OTHER PGAS

HSN 9019 20 90 (therapeutic respiration apparatus, other) is subject to Central Drugs Standard Control Organisation (CDSCO) medical device 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) is required under the E-Waste (Management) Rules, 2022 for qualifying imports, with a micro-enterprise exemption available under the MSMED Act, 2006.

What this is

HSN code

9019 20 90

Chapter

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

Primary regulator

CDSCO · Medical device registration conditions under 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
Confirm the medical device falls within the notified list under G.S.R. 102(E) dated 11-02-2020, and obtain the required CDSCO registration before filing the bill of entry. All conditions attached to the registration, including importer registration and authorised Indian representative requirements, must be satisfied prior to out-of-charge.
G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare notification
2
Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board before import of pulmonary ventilators and accessories. Verify applicability against Schedule I of the E-Waste (Management) Rules, 2022; 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 treating the CDSCO registration as the sole clearance and overlooking the CPCB EPR authorisation, which is a separate upstream obligation. EPR authorisation must be in place before the consignment is imported — it cannot be obtained post-arrival to cure a customs hold — and failure to hold a valid authorisation for notified Schedule I devices exposes the importer to detention and penalty under the E-Waste (Management) Rules, 2022, independent of whether the CDSCO registration is current.

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Frequently asked

Does HSN 9019 20 90 require BIS certification?

No, no BIS Quality Control Order covers this product family. Import of these therapeutic respiration apparatus is governed by Central Drugs Standard Control Organisation registration under G.S.R. 102(E) dated 11-02-2020, with a concurrent EPR authorisation requirement from the Central Pollution Control Board under the E-Waste (Management) Rules, 2022.

Which devices under this HSN require CPCB EPR authorisation?

EPR authorisation under G.S.R. 801(E) dated 02-11-2022 applies to pulmonary ventilators and their accessories listed in Schedule I of the E-Waste (Management) Rules, 2022; micro-enterprises as defined in the MSMED Act, 2006 are exempt from this obligation.

Does the CDSCO registration obligation apply to all products under this residual HSN?

The CDSCO registration requirement applies to devices specifically notified in G.S.R. 102(E) dated 11-02-2020; devices falling outside that notified list are not subject to CDSCO registration, though the CPCB EPR and MOHFW conditions must still be assessed independently.

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