Parts and accessories

Parts and accessories for non-optical microscopes and diffraction apparatus

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9012 90 00 (Parts and accessories for non-optical microscopes and diffraction apparatus) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, where the parts or accessories fall within the medical-device schedule notified by the Ministry of Health and Family Welfare (MOHFW) under G.S.R. 102(E) dated 11-02-2020. Importers must satisfy all conditions, including CDSCO registration, stipulated in that notification before filing the bill of entry.

What this is

HSN code

9012 90 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
Verify whether the specific part or accessory 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 CDSCO registration before importing; shipments of listed devices arriving without valid CDSCO registration are liable to detention and confiscation at the bill-of-entry stage.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
At the bill of entry, ensure all conditions stipulated in G.S.R. 102(E) dated 11-02-2020 are satisfied and that the CDSCO registration certificate is uploaded in e-Sanchit. The customs proper officer will verify the mandatory CDSCO documents before granting out-of-charge.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare

A word of counsel

The most common error on this tariff line is assuming that because the primary product (non-optical microscope or diffraction apparatus) is a research or industrial instrument, its parts and accessories fall outside the medical-device schedule. Where a part or accessory is designed or intended for a medical-device application and is separately listed under G.S.R. 102(E), the CDSCO registration obligation attaches to the accessory independently of the parent instrument's classification — and an unlisted industrial part imported under this HSN alongside a scheduled accessory does not carry the scheduled-device clearance across by association.

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Frequently asked

Does HSN 9012 90 00 require BIS certification?

No, parts and accessories for non-optical microscopes and diffraction apparatus are not covered by any BIS Quality Control Order. Where the part or accessory qualifies as a medical device, the operative framework is CDSCO registration under the Medical Devices Rules, 2017, as notified by the Ministry of Health and Family Welfare under G.S.R. 102(E) dated 11-02-2020.

How does an importer determine whether a specific part or accessory requires CDSCO registration?

The importer must check whether the part or accessory appears in the schedule of medical devices listed in G.S.R. 102(E) dated 11-02-2020; parts not listed in that notification and not otherwise classifiable as medical devices do not attract the CDSCO registration condition.

What happens if a consignment of listed parts arrives without valid CDSCO registration?

The consignment is subject to detention at the port of import; continued non-compliance can result in confiscation and monetary penalty under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017.

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