Hydraulic or pneumatic

Hydraulic or pneumatic automatic regulating instruments and apparatus

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9032 81 00 (Hydraulic or pneumatic automatic regulating or controlling instruments and apparatus) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, where the product falls within medical devices listed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Importers must satisfy all conditions, including device registration with CDSCO, prescribed in that notification before filing the bill of entry.

What this is

HSN code

9032 81 00

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
G.S.R. 102(E) compliance declaration from MOHFW

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Verify whether the specific hydraulic or pneumatic controlling apparatus falls within the medical device categories listed in G.S.R. 102(E) dated 11-02-2020. If it does, obtain the mandatory CDSCO device registration — and an import licence where required — before the bill of entry is filed.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
Confirm that all conditions stipulated in G.S.R. 102(E) dated 11-02-2020 are met at the time of import, including registration status, labelling requirements, and Authorised Indian Representative appointment where the manufacturer is a foreign entity.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare

A word of counsel

The most frequent error on this tariff line is importing on the assumption that a hydraulic or pneumatic apparatus is an industrial instrument beyond the medical-device regime, without first checking its intended use against the G.S.R. 102(E) device list. If the apparatus is designed or intended for a physiological monitoring or therapeutic purpose, CDSCO registration is mandatory regardless of how it is described in the commercial invoice; customs officers are empowered to detain and refer consignments for CDSCO verification where intended use is ambiguous.

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Frequently asked

Does HSN 9032 81 00 require BIS certification?

No, no BIS Quality Control Order covers hydraulic or pneumatic automatic regulating instruments under this tariff line. Where the product qualifies as a medical device listed in G.S.R. 102(E) dated 11-02-2020, import is governed by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017.

How do I determine whether my hydraulic or pneumatic apparatus is a notified medical device under G.S.R. 102(E)?

Cross-reference the product's intended use and description against the device categories enumerated in G.S.R. 102(E) dated 11-02-2020; if the apparatus is intended for diagnosis, prevention, monitoring, or treatment of a human condition, CDSCO registration is required before import.

What happens if a CDSCO-registered device is imported without a valid registration certificate at the bill of entry?

The consignment is liable to detention at the port of import, and customs will not grant out-of-charge until CDSCO registration documentation is produced; prolonged detention attracts demurrage and ground rent, and the importer may face action under the Medical Devices Rules, 2017.

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