Clinical thermometers

Liquid-filled direct-reading clinical thermometers (solid stem, enclosed scale)

BIS QCO APPLICABLE · ISI MARK SCHEME · IS 3055 · CDSCO OVERLAY · MOHFW OVERLAY

HSN 9025 11 10 (clinical thermometers) is covered by a Bureau of Indian Standards Quality Control Order. Conformity to IS 3055 (Part 1) and IS 3055 (Part 2) is mandatory under the ISI Mark Scheme with effect from 9 November 2001, by virtue of G.S.R. 843(E). Central Drugs Standard Control Organisation registration under G.S.R. 102(E) applies as a separate customs-clearance overlay for medical-device compliance.

What this is

HSN code

9025 11 10

Chapter

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

BIS QCO

Applicable · ISI Mark Scheme · CM/L required

Indian Standard

IS 3055 (Part 1) / IS 3055 (Part 2) · effective 09-11-2001

Applicable Partner Government Agencies

BISBIS·Bureau of Indian Standards

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.

Compliance steps

1
Source only from a Bureau of Indian Standards CM/L-licensed manufacturer holding a current licence against IS 3055 (Part 1) for solid-stem-type thermometers or IS 3055 (Part 2) for enclosed-scale-type thermometers. Verify the CM/L number, part-specific scope, and licensed manufacturing facility on the BIS online register before placing the purchase order.
G.S.R. 843(E) dated 09-11-2001 · General Note 2 of the ITC (HS) Import Policy · IS 3055 (Part 1) and IS 3055 (Part 2)
2
Ensure every thermometer bears the ISI mark and the supplier's CM/L number as required under Scheme-I of the BIS (Conformity Assessment) Regulations, 2018. The mark must appear on the product itself; packaging-only marking does not satisfy the statutory requirement.
Scheme-I of the BIS (Conformity Assessment) Regulations, 2018 · BIS Act, 2016
3
Obtain and retain the Central Drugs Standard Control Organisation registration and product approval certificates prior to import. Compliance with all conditions specified under G.S.R. 102(E) is required for medical devices listed therein, in addition to the BIS QCO obligation.
G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare
4
Verify Legal Metrology registration and product approval certificates for the clinical thermometers under Sections 19, 20, and 22 of the Legal Metrology Act, 2009 and Rules 11 to 15 (Eighth Schedule) of the Legal Metrology (General) Rules, 2011. Confirm applicability to the specific product configuration before import.
Sections 19, 20 and 22 of the Legal Metrology Act, 2009 · Rules 11 to 15 (Eighth Schedule) of the Legal Metrology (General) Rules, 2011
5
Quote the supplier's BIS CM/L number, the CDSCO registration reference, and the Legal Metrology approval on the bill of entry. Customs verifies the CM/L against the BIS register in real time; an absent, expired, or part-mismatched licence triggers consignment detention.
G.S.R. 843(E) dated 09-11-2001 · G.S.R. 102(E) dated 11-02-2020 · BIS Act, 2016 · Customs Act, 1962

A word of counsel

The single most common error on this tariff line is treating IS 3055 as a single undivided standard: a CM/L licence against Part 1 (solid-stem type) does not cover Part 2 (enclosed-scale type), and vice versa. Importers who mix product types under one part-specific CM/L face detention at port when customs identifies a mismatch between the declared standard part and the physical product type. Confirm the exact thermometer construction with the supplier and verify the CM/L scope covers the correct part before the purchase order is placed.

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Frequently asked

Does HSN 9025 11 10 require BIS certification?

Yes. Clinical thermometers under this tariff line must conform to IS 3055 (Part 1) for solid-stem types or IS 3055 (Part 2) for enclosed-scale types under the ISI Mark Scheme, mandatory with effect from 9 November 2001 by virtue of G.S.R. 843(E).

Is CDSCO registration required separately from BIS QCO compliance?

Yes. Medical-device compliance under G.S.R. 102(E) dated 11 February 2020, administered by the Central Drugs Standard Control Organisation, is independent of the BIS QCO obligation and must be satisfied concurrently.

Does one CM/L licence cover both solid-stem and enclosed-scale clinical thermometers?

No. IS 3055 Part 1 and Part 2 are distinct standards; a CM/L licence is issued against a specific part, and thermometers of the other construction type are outside its scope.

Does the Legal Metrology requirement apply to every clinical thermometer import?

Legal Metrology registration and product approval under Sections 19, 20, and 22 of the Legal Metrology Act, 2009 apply where the product falls within the notified schedule; importers should verify applicability to their specific thermometer configuration before shipment.

Last verified against gazette notifications: 2026-05-18. Source: BIS / CDSCO / MOHFW / DGFT / Indian Customs CUSDATA.