Pacemakers for stimulating heart muscles, excluding parts and accessories

Cardiac pacemakers for heart muscle stimulation

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9021 50 00 (Pacemakers for stimulating heart muscles) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as a medical device notified under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Import requires full compliance with the registration and import conditions specified in that notification before a bill of entry may be cleared.

What this is

HSN code

9021 50 00

Chapter

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

Primary regulator

CDSCO · Medical Devices Rules, 2017 (notified under G.S.R. 102(E) dated 11-02-2020)

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
MOHFW notification compliance declaration

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Obtain CDSCO registration for the pacemaker as a medical device in compliance with all conditions specified in G.S.R. 102(E) dated 11-02-2020. The registration must be current and valid at the time of filing the bill of entry; clearance will not be granted for devices from unregistered manufacturers or importers.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare
2
Upload all mandatory CDSCO registration and import compliance documents in e-Sanchit before filing the bill of entry. The proper officer will verify that the registration conditions specified under G.S.R. 102(E) are met prior to granting out-of-charge.
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 importing pacemakers under a generic medical-device registration that does not specifically cover the device class notified under G.S.R. 102(E) dated 11-02-2020. A registration covering a broader or adjacent device category does not satisfy the CDSCO conditions attached to this notification; consignments detained at the port of entry pending registration rectification attract demurrage and ground rent that accumulate rapidly given the refrigerated or controlled-storage requirements typical of implantable cardiac devices.

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Frequently asked

Does HSN 9021 50 00 require BIS certification?

No, cardiac pacemakers are not within the BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017, pursuant to G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare.

Which specific conditions under G.S.R. 102(E) dated 11-02-2020 must be met at the bill of entry?

The notification requires CDSCO registration of the device and the importer, and mandates compliance with all import conditions specified therein; the exact conditions should be confirmed against the current text of G.S.R. 102(E) and any subsequent CDSCO guidance, as the regulatory record does not enumerate each sub-condition.

Does the CDSCO registration requirement apply to both the foreign manufacturer and the Indian importer?

Yes. G.S.R. 102(E) dated 11-02-2020 requires registration conditions to be met by the importing entity in India, and CDSCO registration covers both the device and the authorised importer; failure by either party to satisfy the conditions results in detention of the consignment.

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