For testing hardness

Hardness testing machines and appliances for materials

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9024 80 91 (For testing hardness) 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) under G.S.R. 102(E) dated 11-02-2020. Imports of medical devices listed in that notification are permitted only upon satisfaction of all conditions, including CDSCO registration, specified therein.

What this is

HSN code

9024 80 91

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 authorisation from CDSCO

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Verify whether the specific hardness-testing appliance falls within the medical-device category listed in G.S.R. 102(E) dated 11-02-2020. If listed, obtain CDSCO registration for the device before filing the bill of entry; importation without valid registration is prohibited and renders the consignment liable to detention and seizure.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare
2
Ensure all conditions stipulated in G.S.R. 102(E) dated 11-02-2020 are satisfied at the bill-of-entry stage, including any registration documentation to be produced before the proper officer. Upload supporting CDSCO registration evidence in e-Sanchit prior to out-of-charge.
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 on the assumption that hardness-testing apparatus is an industrial instrument outside CDSCO scope, without checking whether the specific device is listed in G.S.R. 102(E) dated 11-02-2020. Scope determination must be made against the notification text before the purchase order is placed; a consignment arriving without CDSCO registration that is subsequently found to be a listed medical device faces detention, ground rent, and potential confiscation with no provision for post-arrival retrospective registration.

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Frequently asked

Does HSN 9024 80 91 require BIS certification?

No, no BIS Quality Control Order covers this product family. Import of hardness-testing machines classified as medical devices 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 hardness-testing appliance is a listed medical device under G.S.R. 102(E)?

The notification text issued by the Ministry of Health and Family Welfare on 11-02-2020 enumerates the covered medical-device categories; the importer must match the specific appliance against that list before filing and obtain CDSCO registration if the device falls within scope.

What happens if the CDSCO registration has expired at the time of import?

An expired registration does not satisfy the conditions of G.S.R. 102(E) dated 11-02-2020, and the consignment will be treated as an unauthorised import of a medical device, exposing the importer to detention, monetary penalty, and confiscation under the Medical Devices Rules, 2017.

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