Other

Unmounted optical elements other than glass (lenses, prisms, mirrors)

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9001 90 90 (Other unmounted optical elements) is subject to Central Drugs Standard Control Organisation (CDSCO) registration requirements under the Medical Devices Rules, 2017, where the product is a medical device listed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Importers must confirm whether the specific optical element falls within the notified medical-device schedule before filing the bill of entry, as unlisted products are governed by general customs clearance only.

What this is

HSN code

9001 90 90

Chapter

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

Primary regulator

CDSCO · G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare

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
Determine whether the specific unmounted optical element being imported is listed in G.S.R. 102(E) dated 11-02-2020 as a notified medical device. If it is, obtain the mandatory CDSCO registration and import licence before shipping, as importation of an unregistered notified medical device attracts detention and penalty under the Drugs and Cosmetics Act, 1940.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare
2
Verify whether the product also qualifies as a telecom product under the Mandatory Testing and Certification of Telecom Equipment (MTCTE) scheme. Compliance with Indian Telegraph (Amendment) Rules, 2017 and DoT notifications TEC/01/2017-TC dated 04-07-2019 and 23-06-2020, as amended vide F.No.5-2/2021-TC/TEC/131 dated 13-06-2022 and F.No.5-2/2024-TC/TEC (Pt.1) dated 25-02-2025, is required for any product on the MTCTE notified list.
Indian Telegraph (Amendment) Rules, 2017 · DoT Notification TEC/01/2017-TC dated 04-07-2019 · F.No.5-2/2021-TC/TEC/131 dated 13-06-2022 · F.No.5-2/2024-TC/TEC (Pt.1) dated 25-02-2025

A word of counsel

The most common error on this residual tariff line is assuming that because the product is an unmounted optical component — not a finished medical instrument — it falls outside the CDSCO medical-device schedule. G.S.R. 102(E) lists specific optical elements as notified medical devices; importing any such listed item without CDSCO registration constitutes an offence under the Drugs and Cosmetics Act, 1940 regardless of the importer's characterisation of the product as a raw optical part. Verify the G.S.R. 102(E) schedule against the product's declared function, not merely its physical form.

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Frequently asked

Does HSN 9001 90 90 require BIS certification?

No, this residual optical-elements tariff line carries no BIS Quality Control Order. Where the product is a notified medical device, import is 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.

How do I determine whether my optical element is a notified medical device under G.S.R. 102(E)?

Cross-check the product's intended function against the schedule published in G.S.R. 102(E) dated 11-02-2020; CDSCO registration and an import licence are mandatory only if the product is listed therein, and the conditions of registration specified in that notification must be met before shipment.

Can the same optical element attract both CDSCO and MTCTE compliance requirements simultaneously?

Yes. An optical element used in a telecom application may independently fall within the MTCTE mandatory-certification list under the Indian Telegraph (Amendment) Rules, 2017, while also being a notified medical device under G.S.R. 102(E); both regimes operate independently and neither exempts the importer from the other.

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