Stroboscopes

Stroboscopes used as listed medical devices

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9029 20 30 (Stroboscopes) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, where the stroboscope is classified as a medical device listed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Import is permitted only upon fulfilment of the registration and other conditions specified in that notification.

What this is

HSN code

9029 20 30

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
MOHFW notification compliance declaration

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Determine whether the stroboscope being imported falls within the medical-device classification established by G.S.R. 102(E) dated 11-02-2020. If so, obtain the mandatory CDSCO registration covering the device class and ensure all conditions of that notification are satisfied before filing the bill of entry.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare
2
Upload the CDSCO registration certificate and any other documents mandated under G.S.R. 102(E) in e-Sanchit at the bill of entry stage. Customs out-of-charge will not be granted for consignments lacking valid PGA registration evidence in the system.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017

A word of counsel

The single most common error on this tariff line is importing stroboscopes without first verifying whether the specific device model falls within the medical-device scope of G.S.R. 102(E) dated 11-02-2020. Industrial and scientific stroboscopes may not be covered, but a stroboscope marketed or intended for medical diagnostic use is squarely within CDSCO jurisdiction; arrival at port without a valid CDSCO registration for a device in scope results in detention and potential confiscation, regardless of the importer's characterisation of end-use.

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Frequently asked

Does HSN 9029 20 30 require BIS certification?

No, stroboscopes under this tariff line are not covered by any BIS Quality Control Order. Where the device falls within the medical-device list under G.S.R. 102(E) dated 11-02-2020, import is governed by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017.

Do all stroboscopes under HSN 9029 20 30 require CDSCO registration, or only those intended for medical use?

Only stroboscopes classified as medical devices under G.S.R. 102(E) dated 11-02-2020 require CDSCO registration; industrial or purely scientific stroboscopes not falling within that notification are not subject to the medical-device regime.

What happens if a stroboscope in scope of G.S.R. 102(E) is imported without a valid CDSCO registration?

The consignment is liable to detention at port and, if the violation is not rectified, to confiscation and monetary penalty under the Medical Devices Rules, 2017, and the Drugs and Cosmetics Act, 1940.

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