Scientigraphic apparatus

Scintigraphic apparatus for medical imaging

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9018 14 00 (Scintigraphic apparatus) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as notified by the Ministry of Health and Family Welfare (MOHFW) vide G.S.R. 102(E) dated 11-02-2020. Import is conditional on registration and all compliance conditions stipulated in G.S.R. 102(E); import of old or refurbished units is additionally governed by CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024.

What this is

HSN code

9018 14 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 authorisation from MOHFW
Old/refurbished 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 the scintigraphic apparatus as a medical device listed under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare. All conditions stipulated in that notification — including importer registration and authorised Indian representative requirements — must be satisfied before the bill of entry is filed.
G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017
2
If the consignment consists of old or refurbished scintigraphic equipment, confirm that the specific equipment model appears on the list of items permitted for import in old/refurbished condition as detailed in CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024. Items not on that list may not be imported in a non-new state.
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 importing a refurbished or second-hand scintigraphic unit on the strength of a valid CDSCO registration alone, without verifying that the equipment appears on the permitted old/refurbished list under CBIC Instructions 08/2024-Customs and 25/2024-Customs. CDSCO registration addresses product safety compliance; eligibility to import in a non-new condition is a separate customs-level determination, and a consignment of unlisted refurbished equipment is liable to detention and re-export regardless of registration status.

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Frequently asked

Does HSN 9018 14 00 require BIS certification?

No, scintigraphic apparatus is not covered by any BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017, as notified by the Ministry of Health and Family Welfare vide G.S.R. 102(E) dated 11-02-2020.

What registration must be completed with CDSCO before filing the bill of entry for scintigraphic apparatus?

The device must be registered under the Medical Devices Rules, 2017, in compliance with all conditions of G.S.R. 102(E) dated 11-02-2020, which includes importer registration with CDSCO and appointment of an authorised Indian representative where required.

Can scintigraphic apparatus be imported in a refurbished or second-hand condition?

Only if the specific equipment model appears on the permitted list under CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024; units not on that list are barred from import in old or refurbished condition.

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