Bone saws, drills and trephines

Bone saws, drills and trephines for surgical use

CDSCO CLEARANCE · MOHFW CLEARANCE · +1 OTHER PGAS

HSN 9018 90 21 (Bone saws, drills and trephines) 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) under the Medical Devices Rules, 2017. Import of used or refurbished high-value medical equipment of this class is additionally restricted under the Ministry of Environment, Forest and Climate Change (MEFCC) Office Memorandum dated 15-12-2023, with permissible categories of old or refurbished equipment governed by CBIC Instruction 08/2024-Customs and Instruction 25/2024-Customs.

What this is

HSN code

9018 90 21

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
Compliance declaration to MOHFW

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
Obtain CDSCO registration for the device under G.S.R. 102(E) dated 11-02-2020 before filing the bill of entry. All conditions prescribed in that notification — including registration of the foreign manufacturer and the Indian importer — must be fulfilled; consignments without a valid CDSCO registration are liable to detention and confiscation.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
Where the equipment is used or refurbished, verify that the specific model falls within the list of old or refurbished equipment permitted for import under CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024. Import of high-end, high-value used or refurbished medical equipment outside the permitted list is Restricted and subject to the MEFCC Office Memorandum dated 15-12-2023.
CBIC Instruction 08/2024-Customs dated 05-04-2024 · CBIC Instruction 25/2024-Customs dated 28-10-2024 · MEFCC O.M. dated 15-12-2023

A word of counsel

The most common error on this tariff line is importing used or refurbished bone saws, drills, or trephines on the strength of CDSCO registration alone, without checking the separate MEFCC-administered restriction on high-end used medical equipment. CDSCO registration is a necessary but not sufficient condition: a consignment of refurbished surgical bone equipment that does not appear in the permitted-equipment list under CBIC Instructions 08/2024-Customs or 25/2024-Customs remains Restricted regardless of CDSCO status, and clearance will be refused at the bill-of-entry stage.

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Frequently asked

Does HSN 9018 90 21 require BIS certification?

No, bone saws, drills and trephines are not covered by any BIS Quality Control Order. 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, with additional restrictions on used or refurbished equipment administered by the Ministry of Environment, Forest and Climate Change.

Are there separate conditions for importing used or refurbished surgical bone instruments under this HSN?

Yes. Import of high-end, high-value used or refurbished medical equipment is Restricted under the MEFCC Office Memorandum dated 15-12-2023; only equipment listed in the annexures to CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024 may be imported in an old or refurbished state.

Does the CDSCO registration requirement apply to both new and refurbished bone surgical instruments?

Yes. G.S.R. 102(E) dated 11-02-2020 applies to all imports of listed medical devices including bone saws, drills and trephines, irrespective of whether the equipment is new or refurbished; the refurbished-equipment restriction under the MEFCC regime applies as an additional overlay, not in substitution of the CDSCO registration requirement.

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