Other

Non-optical microscopes and diffraction apparatus

CDSCO CLEARANCE · MOHFW CLEARANCE · +1 OTHER PGAS

HSN 9012 10 90 (non-optical microscopes and diffraction apparatus) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Import of used or refurbished high-value medical equipment under this tariff line is additionally restricted by conditions notified by the Ministry of Environment, Forest and Climate Change (MEFCC) vide O.M. dated 15-12-2023.

What this is

HSN code

9012 10 90

Chapter

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

Primary regulator

CDSCO · G.S.R. 102(E) dated 11-02-2020 (MOHFW medical devices registration)

Customs documentation

Registration certificate from CDSCO
Import licence from MOHFW
Compliance documentation from MEFCC

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Compliance steps

1
Verify that the specific medical device being imported under HSN 9012 10 90 is listed in G.S.R. 102(E) dated 11-02-2020 and obtain the applicable CDSCO registration before filing the bill of entry. The registration certificate must be uploaded in e-Sanchit as a mandatory document prior to out-of-charge.
G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare
2
If the consignment comprises used or refurbished high-end, high-value medical equipment (other than critical care medical equipment), comply with the additional conditions imposed under the O.M. issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023. Non-compliance renders the consignment liable to detention and re-export.
O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023

A word of counsel

The most common error on this tariff line is assuming that all non-optical microscopes and diffraction apparatus fall outside the CDSCO medical-device registration regime. Whether a particular instrument is listed under G.S.R. 102(E) depends on its intended use and classification as a medical device; instruments with a diagnostic or analytical medical purpose may be captured while identical hardware imported for industrial or research use may not. Misclassification of the end-use triggers CDSCO enforcement at the bill of entry, with consignment detention until registration is established.

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Frequently asked

Does HSN 9012 10 90 require BIS certification?

No, no BIS Quality Control Order covers non-optical microscopes or diffraction apparatus. Import is governed by Central Drugs Standard Control Organisation registration under G.S.R. 102(E) dated 11-02-2020 where the instrument is classified as a medical device, with an additional MEFCC overlay for used or refurbished high-value equipment.

Does the CDSCO registration requirement apply to all non-optical microscopes or only to those used as medical devices?

Registration under G.S.R. 102(E) applies only to instruments listed in that notification as medical devices; non-optical microscopes or diffraction apparatus imported exclusively for industrial or research purposes and not listed therein are not subject to the CDSCO registration condition.

What additional conditions apply to used or refurbished equipment under this tariff line?

Import of high-end, high-value used or refurbished medical equipment other than critical care medical equipment is restricted and subject to conditions specified in the O.M. issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023; critical care medical equipment is treated separately under that O.M.

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