Mechano-therapy appliances

Mechano-therapy appliances and massage apparatus

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9019 10 10 (Mechano-therapy appliances) 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) via G.S.R. 102(E) dated 11-02-2020. Devices listed in that notification must satisfy all conditions — including importer and device registration with CDSCO — before a bill of entry may be cleared.

What this is

HSN code

9019 10 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

Device registration certificate from CDSCO
Importer registration from CDSCO
MOHFW notification compliance declaration

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Confirm whether the specific mechano-therapy appliance or massage apparatus is listed in G.S.R. 102(E) dated 11-02-2020. If listed, obtain the requisite CDSCO device registration and ensure the importer holds a valid importer registration under the Medical Devices Rules, 2017 before filing the bill of entry.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare
2
Upload all CDSCO registration documents and compliance evidence in e-Sanchit at the bill of entry stage. Customs out-of-charge will not be granted for listed medical devices unless the mandatory CDSCO registration conditions prescribed in G.S.R. 102(E) are satisfied and verified.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017

A word of counsel

The most common error on this tariff line is assuming that mechano-therapy and massage apparatus fall outside the medical-device regulatory perimeter because they appear mechanical rather than clinical. Whether a device is captured depends entirely on its listing in G.S.R. 102(E) dated 11-02-2020; an unlisted appliance is not automatically free of CDSCO requirements if it meets the definition of a medical device under the Medical Devices Rules, 2017. Importers should verify listing status before dispatch to avoid detention and demurrage at port.

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Frequently asked

Does HSN 9019 10 10 require BIS certification?

No, no BIS Quality Control Order covers mechano-therapy appliances or massage apparatus. 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.

How do I determine whether my specific device is captured by G.S.R. 102(E)?

G.S.R. 102(E) dated 11-02-2020 enumerates the categories of medical devices subject to CDSCO registration; importers must cross-check the appliance description and intended use against that notification's schedule before shipment.

What happens if a listed device is imported without CDSCO registration?

Importation of a listed medical device without the requisite CDSCO registration constitutes a violation of the Medical Devices Rules, 2017, exposing the consignment to detention, seizure, and refusal of out-of-charge by customs.

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