Other

Mounted optical elements for instruments and apparatus

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9002 19 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 medical devices listed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Registration with CDSCO and compliance with all conditions stipulated in G.S.R. 102(E) are mandatory before import clearance at the bill of entry.

What this is

HSN code

9002 19 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
Confirm whether the specific mounted optical element being imported is listed as a medical device in G.S.R. 102(E) dated 11-02-2020. If it is, obtain CDSCO registration for the device and ensure all conditions stipulated in 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 mandatory documents in e-Sanchit at the bill of entry stage. Consignments arriving without the required CDSCO registration are liable to detention and refusal of out-of-charge.
Medical Devices Rules, 2017 · G.S.R. 102(E) dated 11-02-2020

A word of counsel

The most common error on this tariff line is assuming that all mounted optical elements under HSN 9002 19 00 fall outside CDSCO's purview because they are broadly classified as instrument parts rather than medical devices. The scope of G.S.R. 102(E) dated 11-02-2020 is device-specific: if the optical element is a component of or a fitting for a notified medical device, the full CDSCO registration and MOHFW compliance regime attaches. Importers who skip the scope-check and file without registration risk consignment detention and potential confiscation.

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Frequently asked

Does HSN 9002 19 00 require BIS certification?

No, no BIS Quality Control Order covers mounted optical elements for instruments under this tariff line. Import is instead governed by the Central Drugs Standard Control Organisation under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare, where the product qualifies as a notified medical device.

Does CDSCO registration apply to all goods under HSN 9002 19 00 or only to specific products?

Registration applies only where the mounted optical element is listed as a medical device in G.S.R. 102(E) dated 11-02-2020; optical elements imported as general instrument parts that do not fall within that notification's scope are not subject to the CDSCO regime.

What happens if a consignment arrives without CDSCO registration when the device is listed in G.S.R. 102(E)?

Customs will refuse out-of-charge, and the consignment is liable to detention; prolonged non-compliance may result in re-export or confiscation under the Medical Devices Rules, 2017.

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