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Parts for balances of 5 cg or better sensitivity

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9016 00 90 (Parts for precision balances) 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. Importers must comply with all conditions, including CDSCO registration, prescribed in that notification before filing the bill of entry.

What this is
HSN code
9016 00 90
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 licence from MOHFW
Applicable Partner Government Agencies
CDSCOCDSCO·Central Drugs Standard Control Organisation
MOHFWMOHFW·Ministry of Health and Family Welfare
Compliance steps
  1. 1
    Confirm that the specific parts being imported fall within the scope of medical devices listed in G.S.R. 102(E) dated 11-02-2020. Obtain the requisite CDSCO registration covering these parts before the bill of entry is filed at the port of import.
    G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare
  2. 2
    Ensure all conditions prescribed in G.S.R. 102(E) dated 11-02-2020 are satisfied at the bill of entry stage, including valid CDSCO registration documentation. Non-compliance renders the consignment liable to detention and refusal of out-of-charge by the proper officer.
    G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017
A word of counsel

The most common error on this tariff line is assuming that parts for precision balances fall outside the medical-device registration requirement because they are components rather than finished instruments. G.S.R. 102(E) dated 11-02-2020 applies to listed medical devices and their parts; importing without a valid CDSCO registration — even for components — exposes the consignment to detention and the importer to enforcement action under the Medical Devices Rules, 2017.

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Frequently asked
Does HSN 9016 00 90 require BIS certification?
No, no BIS Quality Control Order covers parts for precision balances under this tariff line. Import is governed by the Central Drugs Standard Control Organisation registration requirement under the Medical Devices Rules, 2017, as notified by MOHFW vide G.S.R. 102(E) dated 11-02-2020.
Are all parts for precision balances subject to CDSCO registration, or only certain categories?
Only those parts that fall within the scope of medical devices listed in G.S.R. 102(E) dated 11-02-2020 attract the CDSCO registration requirement; importers should verify the specific listing against the notification before filing the bill of entry.
What happens if the CDSCO registration is not in place at the time of import?
A consignment without the requisite CDSCO registration is liable to detention at the port and refusal of out-of-charge, with potential for confiscation and monetary penalty under the Medical Devices Rules, 2017.
Last verified against gazette notifications: 2026-05-16. Source: CDSCO / MOHFW / Indian Customs CUSDATA.
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