Cardiac catheters
Cardiac catheters for medical and surgical use
HSN 9018 39 20 (Cardiac catheters) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as a listed medical device under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Import requires CDSCO registration of both the device and the foreign manufacturer, with mandatory e-Sanchit document upload before customs out-of-charge.
- Registration certificate from CDSCO
- Batch release certificate from CDSCO
- Certificate of Analysis from manufacturer
- 1Obtain CDSCO registration for the cardiac catheter as a listed medical device under G.S.R. 102(E) dated 11-02-2020. The foreign manufacturing facility must also be registered with CDSCO; import is not permitted until both device registration and manufacturer registration are current and valid.G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare · Medical Devices Rules, 2017
- 2Upload the mandatory e-Sanchit documents before filing the bill of entry: Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc). The proper officer will verify these uploads prior to granting out-of-charge.CBIC CCR PGA facilitation requirement · document codes 0010dc, 0030dc, 0110dc
- 3If importing cardiac catheters in old or refurbished condition, confirm the specific model appears on the permitted list under CBIC Instruction 08/2024-Customs dated 05-04-2024 and CBIC Instruction 25/2024-Customs dated 28-10-2024. Import of refurbished medical equipment not on that list is not permitted.CBIC Instruction 08/2024-Customs dated 05-04-2024 · CBIC Instruction 25/2024-Customs dated 28-10-2024
The most common error on this tariff line is presenting a valid CDSCO device registration while the foreign manufacturer's own registration has lapsed or was never obtained — both registrations are independently required under G.S.R. 102(E), and a gap in either triggers consignment detention at the port. Importers sourcing refurbished cardiac catheters face a separate gatekeeping layer: the permitted-equipment list under the two 2024 CBIC Instructions is equipment-specific, and a model absent from that list cannot be cleared regardless of CDSCO registration status.