Scintillator counters

Scintillator counters for ionising radiation detection

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9030 89 10 (Scintillator counters) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as a medical device notified under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Import without a valid CDSCO registration renders the consignment liable to detention and confiscation at the bill-of-entry stage.

What this is

HSN code

9030 89 10

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

Import registration from CDSCO
G.S.R. 102(E) compliance declaration to MOHFW
Certificate of conformity from manufacturer

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Obtain a valid CDSCO import registration for scintillator counters as a medical device notified under G.S.R. 102(E) dated 11-02-2020. The registration must cover the specific device class and be current at the time the bill of entry is filed; import of an unregistered listed device is prohibited under the Medical Devices Rules, 2017.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
Upload the CDSCO import registration certificate and all conditions of registration in e-Sanchit before filing the bill of entry. The proper officer will verify compliance with the registration conditions specified in G.S.R. 102(E) before granting out-of-charge.
G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017

A word of counsel

The most common error on this tariff line is filing the bill of entry under the broader Chapter 90 instrument category without uploading the CDSCO medical-device registration, on the mistaken assumption that scintillator counters are purely scientific instruments exempt from the device regime. G.S.R. 102(E) dated 11-02-2020 explicitly brings radiation-detection instruments used in medical contexts within the notified medical-device list; customs officers are instructed to verify CDSCO registration before out-of-charge, and the absence of registration results in consignment detention and potential seizure.

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Frequently asked

Does HSN 9030 89 10 require BIS certification?

No, scintillator counters are not within the BIS Quality Control Order regime; no BIS QCO covers this product family. 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.

What registration conditions under G.S.R. 102(E) must be met at the bill of entry?

The importer must hold a CDSCO import registration covering the specific scintillator counter model and must have uploaded the registration certificate in e-Sanchit; the full conditions specified in G.S.R. 102(E) dated 11-02-2020, including labelling and post-market surveillance obligations, are binding from the date of import.

Does the CDSCO registration requirement apply to scintillator counters imported for non-medical research use?

The obligation flows from the device's listing in G.S.R. 102(E) dated 11-02-2020, which does not provide a blanket research-use carve-out; importers should seek CDSCO guidance on any applicable exemption before filing, as importing without registration exposes the consignment to seizure and the importer to prosecution under the Medical Devices Rules, 2017.

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