Monocular and refracting telescopes

Monocular and refracting telescopes as medical devices

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9005 80 10 (Monocular and refracting telescopes) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, where the instrument is listed as a medical device in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Compliance with all registration and import conditions specified in that notification is mandatory before a bill of entry can be granted out-of-charge.

What this is

HSN code

9005 80 10

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, 2017)

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 monocular or refracting telescope being imported falls within the medical-device categories listed in G.S.R. 102(E) dated 11-02-2020. If so, obtain the requisite CDSCO registration for the device and the importer before filing the bill of entry.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare
2
Ensure all import conditions specified in G.S.R. 102(E) dated 11-02-2020 are met at the bill-of-entry stage, including valid CDSCO registration credentials uploaded in e-Sanchit. Consignments lacking current CDSCO registration are liable to detention pending regularisation.
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 telescopes classified under HSN 9005 80 10 are purely optical instruments and therefore outside the medical-device regulatory perimeter. Where the product is intended for ophthalmic or other medical use and is listed in G.S.R. 102(E), CDSCO registration is mandatory; importing without it attracts consignment detention and potential confiscation under the Medical Devices Rules, 2017. Confirm the intended end-use and device listing status before the purchase order is placed.

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Frequently asked

Does HSN 9005 80 10 require BIS certification?

No, monocular and refracting telescopes are not covered by any BIS Quality Control Order. Where the instrument 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.

Do all monocular and refracting telescopes under this HSN require CDSCO registration?

No — only those instruments that are listed as medical devices in G.S.R. 102(E) dated 11-02-2020 attract the CDSCO registration requirement; purely non-medical optical telescopes imported under this tariff line fall outside that notification's scope.

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

The consignment is liable to detention at the port of import; continued non-compliance can result in confiscation or re-export under the Medical Devices Rules, 2017, without prejudice to monetary penalty proceedings.

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