Electric balances

Electric balances of 5 cg or better sensitivity

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9016 00 10 (Electric balances) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, for units listed as medical devices in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Legal Metrology Act, 2009 verification of product approval and registration certificates applies as an additional overlay for non-automatic weighing instruments where applicable.

What this is

HSN code

9016 00 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

Registration certificate from CDSCO
Product approval certificate from Legal Metrology
MOHFW compliance declaration

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Confirm whether the electric balance being imported is listed in G.S.R. 102(E) dated 11-02-2020 as a notified medical device. If listed, obtain CDSCO registration covering the specific device class and ensure the registration certificate is current and uploaded at the bill of entry.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
Verify Legal Metrology registration and product approval certificates if the electric balance falls within the scope of non-automatic weighing instruments. References are Sections 19, 20 and 22 of the Legal Metrology Act, 2009 and Rules 11 to 15 of the Seventh Schedule of the Legal Metrology (General) Rules, 2011.
Sections 19, 20 and 22 of the Legal Metrology Act, 2009 · Rules 11–15, Seventh Schedule, Legal Metrology (General) Rules, 2011

A word of counsel

The most common error on this tariff line is failing to determine upfront whether the specific electric balance is classified as a medical device under G.S.R. 102(E). An instrument used in clinical or diagnostic settings that falls within the notified list but arrives without CDSCO registration is liable to detention and refusal of out-of-charge; the Legal Metrology overlay is a separate and concurrent requirement for weighing instruments and does not substitute for CDSCO clearance where the device notification applies.

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Frequently asked

Does HSN 9016 00 10 require BIS certification?

No, electric balances of 5 cg or better sensitivity are not covered by any BIS Quality Control Order. Import compliance for this tariff line is governed by CDSCO registration under the Medical Devices Rules, 2017 for notified medical devices, and by Legal Metrology product approval requirements for non-automatic weighing instruments where applicable.

Which electric balances are subject to CDSCO registration under this tariff line?

Only those devices listed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare are subject to mandatory CDSCO registration; balances not within that notified list are not subject to the medical-device registration requirement, though the Legal Metrology overlay may still apply.

Does the Legal Metrology requirement apply to all electric balances imported under HSN 9016 00 10?

The Legal Metrology registration and product approval certificate requirement applies to non-automatic weighing instruments within the scope of Sections 19, 20 and 22 of the Legal Metrology Act, 2009 and Rules 11 to 15 of the Seventh Schedule of the Legal Metrology (General) Rules, 2011; importers should confirm applicability for the specific instrument against those provisions before filing the bill of entry.

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