Digital thermometers

Digital thermometers for clinical and industrial use

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9025 19 10 (Digital thermometers) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, for devices notified under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Legal Metrology registration and product-approval certificates apply as a concurrent overlay under Sections 19, 20 and 22 of the Legal Metrology Act, 2009.

What this is

HSN code

9025 19 10

Chapter

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

Primary regulator

CDSCO · G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare

Customs documentation

CDSCO registration certificate from CDSCO
Importer registration certificate from Legal Metrology
Product approval certificate from Legal Metrology

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Confirm that the digital thermometer model is listed under G.S.R. 102(E) dated 11-02-2020 and obtain CDSCO import registration before filing the bill of entry. Where the device qualifies as a medical device under that notification, compliance with all CDSCO conditions — including importer registration — is mandatory prior to customs clearance.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare
2
For clinical thermometers, verify that the Legal Metrology importer registration and product-approval certificates are current and upload the certificate of registration of importer of weights and measures (document code 101lm1) in e-Sanchit before out-of-charge. Non-upload will result in detention of the consignment at the port.
Sections 19, 20 and 22 of the Legal Metrology Act, 2009 · Rules 11 to 15, Eighth Schedule, Legal Metrology (General) Rules, 2011 as amended

A word of counsel

The most common error on this tariff line is assuming the CDSCO medical-device registration covers the Legal Metrology obligation — it does not. Clinical thermometers are subject to both regimes independently: a current CDSCO registration does not discharge the requirement for Legal Metrology product-approval and importer registration under the Eighth Schedule of the Legal Metrology (General) Rules, 2011, and failure to upload document code 101lm1 in e-Sanchit will hold the consignment at out-of-charge irrespective of CDSCO clearance.

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Frequently asked

Does HSN 9025 19 10 require BIS certification?

No, digital thermometers under this tariff line are not subject to a BIS Quality Control Order. Import is governed by Central Drugs Standard Control Organisation registration requirements under G.S.R. 102(E) dated 11-02-2020, with a concurrent Legal Metrology product-approval obligation for clinical thermometers.

Is the Legal Metrology registration required for all digital thermometers or only clinical types?

The CCR specifically references Legal Metrology registration and product-approval certificates for clinical thermometers; the obligation under Sections 19, 20 and 22 of the Legal Metrology Act, 2009 and Rules 11 to 15 of the Eighth Schedule of the Legal Metrology (General) Rules, 2011 applies where the device falls within that category.

What happens if CDSCO registration is obtained but the device is not listed under G.S.R. 102(E)?

Digital thermometers not captured under G.S.R. 102(E) dated 11-02-2020 do not attract the CDSCO medical-device registration condition, but the Legal Metrology obligations for clinical thermometers remain independently applicable; misclassification of device scope is a distinct compliance risk that can result in consignment detention.

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