Stereoscopic microscopes

Stereoscopic microscopes for medical or surgical use

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9011 10 00 (Stereoscopic microscopes) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as administered by the Ministry of Health and Family Welfare (MOHFW) pursuant to G.S.R. 102(E) dated 11-02-2020. Import is conditional on compliance with all registration and licensing obligations specified in that notification before a bill of entry may be filed.

What this is

HSN code

9011 10 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
Obtain the requisite CDSCO registration for the stereoscopic microscope prior to import. The device must be listed or registrable under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare, and all registration conditions specified therein must be satisfied before the bill of entry is filed.
G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017
2
Upload the CDSCO registration certificate and any import licence issued under the Medical Devices Rules, 2017 in e-Sanchit at the bill of entry stage. Customs out-of-charge will not be granted until the mandatory CDSCO documentation is verified and present in the system.
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 importing stereoscopic microscopes intended for medical or surgical applications without first confirming whether the specific model and intended use place it squarely within the notified device categories under G.S.R. 102(E). A device that is functionally a medical instrument but imported without CDSCO registration is liable to detention and confiscation at the port of entry; the registration must cover the precise model, not merely the product class.

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Frequently asked

Does HSN 9011 10 00 require BIS certification?

No, no BIS Quality Control Order covers stereoscopic microscopes under this tariff line. Import is governed by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017, pursuant to the Ministry of Health and Family Welfare notification G.S.R. 102(E) dated 11-02-2020.

Is CDSCO registration required even for stereoscopic microscopes imported for non-medical laboratory use?

The CDSCO registration obligation under G.S.R. 102(E) applies to medical devices listed in that notification; importers should confirm whether their specific model and intended application fall within the notified categories before assuming the registration requirement does not apply.

What happens if a consignment arrives without a valid CDSCO registration?

A consignment of notified medical devices arriving without a valid CDSCO registration is liable to detention at port, with the importer facing potential confiscation and monetary penalty under the Medical Devices Rules, 2017, with no out-of-charge until compliance is demonstrated.

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