Retractors, spatulaprobes, hooks dialators, sounds, mallets

Surgical retractors, probes, hooks, dilators and sounds

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 90 25 (surgical retractors, spatula probes, hooks, dilators, sounds, and mallets) 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 is conditional on compliance with the registration and market-authorisation requirements specified in that notification, with old or refurbished equipment subject to a separately notified permitted-equipment list.

What this is

HSN code

9018 90 25

Chapter

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

Primary regulator

CDSCO · Medical Devices Rules (G.S.R. 102(E) dated 11-02-2020, MOHFW)

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
G.S.R. 102(E) compliance declaration

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Obtain CDSCO registration for each medical device class covered under G.S.R. 102(E) dated 11-02-2020 before filing the bill of entry. The registration must cover the specific device type — retractor, probe, hook, dilator, sound, or mallet — and the foreign manufacturer must be registered or have an Authorised Indian Representative on record with CDSCO.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare
2
If importing old or refurbished surgical instruments, verify that the specific equipment appears on the permitted list issued under CBIC Instruction 08/2024-Customs dated 05-04-2024 and as updated by CBIC Instruction 25/2024-Customs dated 28-10-2024. Devices not on that list are not importable in old or refurbished condition and are liable to detention and re-export.
CBIC Instruction 08/2024-Customs dated 05-04-2024 · CBIC Instruction 25/2024-Customs dated 28-10-2024

A word of counsel

The most common error on this tariff line is assuming that all surgical hand instruments falling under HSN 9018 90 25 occupy the same regulatory track regardless of condition. New devices require CDSCO registration per G.S.R. 102(E); old or refurbished devices face an additional gatekeeping step — they must appear on the CBIC-notified permitted-equipment list. Consignments of refurbished instruments not on that list face detention and compulsory re-export, with demurrage and ground rent accruing against the importer.

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Frequently asked

Does HSN 9018 90 25 require BIS certification?

No, surgical retractors, probes, hooks, dilators, sounds, and mallets are not covered by any BIS Quality Control Order. Import is governed by Central Drugs Standard Control Organisation registration under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare.

Which old or refurbished surgical instruments are permitted for import under this HSN?

Only devices appearing on the permitted list issued under CBIC Instruction 08/2024-Customs dated 05-04-2024 and updated by CBIC Instruction 25/2024-Customs dated 28-10-2024 may be imported in old or refurbished condition; instruments not on that list are barred.

Does the foreign manufacturer need to be registered with CDSCO for devices under G.S.R. 102(E)?

Yes. G.S.R. 102(E) requires the foreign manufacturing facility to be registered with CDSCO or to appoint an Authorised Indian Representative; import of devices from an unregistered foreign manufacturer is not permitted and the consignment is liable to detention at the port.

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