Electronic automatic regulators

Electronic automatic regulators for medical device use

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9032 89 10 (Electronic automatic regulators) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, where the device falls within the scope of G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Import of medical devices listed in that notification is conditional upon compliance with registration and other conditions specified therein.

What this is

HSN code

9032 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

Registration certificate from CDSCO
Import licence from CDSCO

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Verify whether the specific electronic automatic regulator falls within the medical device categories listed in G.S.R. 102(E) dated 11-02-2020. If listed, obtain the mandatory CDSCO registration for the device before filing the bill of entry; imports without a current registration are liable to detention and refusal of out-of-charge.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare
2
Ensure all conditions stipulated in G.S.R. 102(E) dated 11-02-2020 — including registration of the foreign manufacturer and the authorised Indian representative — are satisfied and that supporting documents are uploaded in e-Sanchit at the bill of entry stage.
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 frequent error on this tariff line is assuming that an electronic automatic regulator is outside CDSCO's scope because it is an instrument rather than a pharmaceutical. G.S.R. 102(E) covers specific instrument-category medical devices; an importer who has not confirmed whether the particular device model is listed risks consignment detention at the bill of entry stage, with no rectification route short of obtaining full CDSCO registration retrospectively.

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Frequently asked

Does HSN 9032 89 10 require BIS certification?

No, no BIS Quality Control Order covers electronic automatic regulators under this tariff line. Import is instead governed by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017, where the device is listed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare.

How do I determine whether my electronic automatic regulator is a listed medical device under G.S.R. 102(E)?

Cross-reference the device's intended use and description against the categories enumerated in G.S.R. 102(E) dated 11-02-2020; devices intended for physiological monitoring, regulation, or therapeutic control typically fall within the notified categories and require CDSCO registration before import.

What happens if the CDSCO registration is not obtained before the bill of entry is filed?

The consignment will be detained at the port of import pending regularisation; if registration cannot be established, the goods are liable to re-export or confiscation under the Medical Devices Rules, 2017.

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