OTHER BREATHING APPLIANCES AND GAS MASKS, EXCLUDING PROTECTIVE MASKS HAVING NEITHER MECHANICAL PARTS NOR REPLACEABLE FILTERS

Breathing appliances and gas masks with mechanical parts or replaceable filters

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9020 00 00 (breathing appliances and gas masks) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as a medical device notified in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Import is conditional on CDSCO registration compliance and any additional conditions specified in that gazette notification.

What this is

HSN code

9020 00 00

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
Import licence from CDSCO
G.S.R. 102(E) compliance declaration to MOHFW

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Obtain CDSCO registration for the breathing appliance or gas mask as a medical device listed under G.S.R. 102(E) dated 11-02-2020. The registration must be current and all conditions stipulated in that notification must be met before the bill of entry is filed.
G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare notification
2
Upload the CDSCO registration certificate and any mandatory compliance documentation in e-Sanchit at the bill of entry stage. The proper officer will verify the uploaded documents before granting out-of-charge; consignments without valid CDSCO registration on record are liable to detention.
G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017

A word of counsel

The most common error on this tariff line is importing under the assumption that only simple protective masks require no CDSCO clearance, while overlooking that breathing appliances and gas masks with mechanical parts or replaceable filters are explicitly listed medical devices under G.S.R. 102(E) dated 11-02-2020. Importers should confirm their specific product variant falls within or outside the notified device scope before shipment; an incorrectly classified consignment will be detained at the port of entry pending CDSCO verification.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 9020 00 00 require BIS certification?

No, no BIS Quality Control Order covers breathing appliances and gas masks under this tariff line. Import is governed by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017, pursuant to G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare.

Does the CDSCO registration requirement apply to all breathing appliances under this HSN?

The registration obligation applies to devices listed in G.S.R. 102(E) dated 11-02-2020; the exclusion in the tariff descriptor — protective masks having neither mechanical parts nor replaceable filters — falls outside this HSN entirely, so every product classified here is within the notified medical device scope.

What happens if a consignment arrives without a current CDSCO registration?

A consignment without valid CDSCO registration is liable to detention at the port of entry, with demurrage and ground rent accruing until either the registration is produced or the consignment is re-exported; confiscation and monetary penalty are available enforcement outcomes under the Medical Devices Rules, 2017.

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