Other

Mounted optical elements for instruments or apparatus

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9002 90 00 (mounted optical elements, other) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, where the product falls within the medical-device schedule notified by the Ministry of Health and Family Welfare (MOHFW) vide G.S.R. 102(E) dated 11-02-2020. Importers must comply with all conditions of that notification, including CDSCO registration, before filing the bill of entry.

What this is

HSN code

9002 90 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
MOHFW notification compliance declaration

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Verify whether the specific mounted optical element falls within the medical-device categories listed in G.S.R. 102(E) dated 11-02-2020. If it does, obtain the mandatory CDSCO registration for the device and the importer before shipment is dispatched.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
Ensure all conditions specified in G.S.R. 102(E) dated 11-02-2020 are met at the bill-of-entry stage, including upload of the CDSCO registration certificate and any import licence in e-Sanchit. Non-compliance renders the consignment liable to detention and refusal of out-of-charge.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare

A word of counsel

The most common error on this tariff line is assuming that a mounted optical element is outside the medical-device regime because it is a component or fitting rather than a finished device. G.S.R. 102(E) covers device categories broadly; importers who skip the CDSCO scope-check and file the bill of entry without a registration certificate face consignment detention, demurrage, and potential confiscation under the Medical Devices Rules, 2017.

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Frequently asked

Does HSN 9002 90 00 require BIS certification?

No, no BIS Quality Control Order covers this tariff line. Where the mounted optical element qualifies as a medical device 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.

How do I determine if my optical element is covered by G.S.R. 102(E) dated 11-02-2020?

Cross-check the device description against the categories listed in G.S.R. 102(E); if the element is intended for a medical purpose or fits a listed device category, CDSCO registration is mandatory before import.

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

An expired registration is treated as non-compliance with G.S.R. 102(E), and the consignment is liable to detention at the port of entry until a current registration is produced; renewal should be secured well before the shipment date.

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