Other devices, appliances and instrument

Other optical appliances and instruments (non-laser)

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9013 80 00 (Other devices, appliances and instruments) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, where the imported article falls within the medical-device categories notified by the Ministry of Health and Family Welfare (MOHFW) under G.S.R. 102(E) dated 11-02-2020. Consignments of listed medical devices must satisfy all registration and compliance conditions specified in that notification before a bill of entry is cleared.

What this is

HSN code

9013 80 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
Compliance declaration from MOHFW

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Verify whether the specific optical or medical-device article under HSN 9013 80 00 is listed in G.S.R. 102(E) dated 11-02-2020. If listed, obtain the mandatory CDSCO registration for the device and the importer before filing the bill of entry; unregistered listed devices are not permitted to be cleared.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
Upload all CDSCO registration and compliance documents in e-Sanchit at the bill of entry stage. Ensure all conditions attached to the CDSCO registration — including labelling, authorised Indian representative, and post-market surveillance obligations — are met 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 assuming that because the HSN is a residual 'other' category, the device falls outside the G.S.R. 102(E) medical-device schedule. Importers must affirmatively determine, against the notified list, whether their specific article is a listed medical device; a wrong classification that bypasses CDSCO registration exposes the consignment to detention and seizure under the Drugs and Cosmetics Act, 1940, with personal liability for the authorised Indian representative.

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Frequently asked

Does HSN 9013 80 00 require BIS certification?

No, no BIS Quality Control Order covers this residual optical-instruments tariff line. Where the imported article is a listed medical device, import 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 does an importer determine whether a specific article under this HSN requires CDSCO registration?

The importer must check whether the article appears in the schedule of notified medical devices under G.S.R. 102(E) dated 11-02-2020; devices not listed in that notification are not subject to the CDSCO registration requirement under this tariff line.

What happens if a listed medical device is imported without CDSCO registration?

The consignment is liable to detention at the port of import, and clearance will be refused until valid CDSCO registration is produced; continued non-compliance can result in confiscation and prosecution under the Drugs and Cosmetics Act, 1940.

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