Lasers, other than laser diodes

Lasers other than laser diodes (non-diode laser systems)

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9013 20 00 (Lasers, other than laser diodes) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under G.S.R. 102(E) dated 11-02-2020, issued by the Ministry of Health and Family Welfare (MOHFW), where the laser system is classified as a medical device. Importers must comply with all conditions, including device registration with CDSCO, before filing the bill of entry.

What this is

HSN code

9013 20 00

Chapter

90 · Optical, photographic, measuring, checking, precision, medical or surgical instruments

Primary regulator

CDSCO · G.S.R. 102(E) dated 11-02-2020 (Medical Devices Rules, medical device registration)

Customs documentation

Device registration 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 laser system being imported is listed as a medical device under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare. If listed, obtain the requisite CDSCO registration before shipment; import without registration renders the consignment liable to detention and confiscation.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare
2
Upload all CDSCO registration documentation and supporting compliance evidence in e-Sanchit at the bill of entry stage. The customs proper officer will verify CDSCO registration status before granting out-of-charge.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · CDSCO registration conditions

A word of counsel

The most common error on this tariff line is assuming that industrial or scientific lasers falling under HSN 9013 20 00 are automatically outside the medical-device regime. Whether a laser system triggers CDSCO registration under G.S.R. 102(E) depends on its intended use and the device classification notified therein — not on the tariff heading alone. An importer who ships without first verifying device-list coverage risks consignment detention at the port and potential confiscation under the Drugs and Cosmetics Act, 1940.

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Frequently asked

Does HSN 9013 20 00 require BIS certification?

No, no BIS Quality Control Order covers lasers other than laser diodes under this tariff line. Import is governed by Central Drugs Standard Control Organisation registration requirements under G.S.R. 102(E) dated 11-02-2020, where the device falls within the medical-device classification notified by the Ministry of Health and Family Welfare.

How do I determine whether my laser system is covered by G.S.R. 102(E) and requires CDSCO registration?

Cross-check the laser's intended use and technical description against the device categories listed in G.S.R. 102(E) dated 11-02-2020; only laser systems notified as medical devices in that notification require CDSCO registration for import.

What happens if a laser device covered by G.S.R. 102(E) is imported without CDSCO registration?

The consignment is liable to detention at the port of import; continued non-compliance can result in confiscation and monetary penalty under the Drugs and Cosmetics Act, 1940, which governs imported medical devices.

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