Fibrescopes

Medical fibrescopes for diagnostic or surgical use

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 90 95 (Fibrescopes) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as a medical device listed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Importers must comply with all conditions specified in that notification, including CDSCO registration, before a bill of entry is filed. Additional controls under CBIC Instruction 08/2024-Customs and Instruction 25/2024-Customs govern the permissibility of old or refurbished equipment.

What this is

HSN code

9018 90 95

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
Refurbished-equipment approval from CBIC

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Obtain CDSCO registration for fibrescopes as a medical device listed under G.S.R. 102(E) dated 11-02-2020. The registration must be current and the importer must satisfy all conditions specified in that MOHFW notification before the bill of entry is presented at customs.
G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017
2
If importing fibrescopes in old or refurbished condition, verify that the specific equipment model appears on the permissible list published under CBIC Instruction 08/2024-Customs dated 05-04-2024 and updated by CBIC Instruction 25/2024-Customs dated 28-10-2024. Import of old or refurbished medical devices not on that list is not permitted.
CBIC Instruction 08/2024-Customs dated 05-04-2024 · CBIC Instruction 25/2024-Customs dated 28-10-2024

A word of counsel

The most frequent error on this tariff line is assuming that a valid CDSCO registration for a new fibrescope model automatically covers the import of refurbished units of the same model. The CBIC Instructions 08/2024-Customs and 25/2024-Customs impose a separate equipment-specific permissibility check for old or refurbished state; a consignment of refurbished fibrescopes that is not on the approved list faces detention and potential re-export regardless of the currency of the CDSCO registration.

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Frequently asked

Does HSN 9018 90 95 require BIS certification?

No, fibrescopes classified under HSN 9018 90 95 are not covered by any BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017, pursuant to G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare.

Which CBIC instructions govern the import of old or refurbished fibrescopes?

CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024 together specify the list of medical equipment permissible for import in old or refurbished condition; fibrescopes must appear on that list or the consignment will be refused out-of-charge.

Is a foreign manufacturer required to be registered with CDSCO before exporting fibrescopes to India?

Yes. G.S.R. 102(E) dated 11-02-2020 requires compliance with all registration conditions specified therein, which include CDSCO registration covering the manufacturing establishment; import from an unregistered foreign facility is not permitted under the Medical Devices Rules, 2017.

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