Other
Tubular metal needles and needles for sutures, other
HSN 9018 32 90 (Other tubular metal needles and needles for sutures) 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) via G.S.R. 102(E) dated 11-02-2020. Import is conditional on CDSCO registration and compliance with all conditions specified in that notification, with mandatory document upload in e-Sanchit before customs out-of-charge.
- Registration certificate from CDSCO
- Batch release certificate from CDSCO
- Certificate of analysis from CDSCO
- 1Obtain CDSCO registration for the medical device under the conditions prescribed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare. Registration must cover the specific category of tubular metal needles or suture needles being imported, and the certificate must be current at the time of filing the bill of entry.G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017
- 2Upload all three mandatory documents in e-Sanchit before the bill of entry is filed: Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc). The proper officer must verify these uploads before granting out-of-charge where the bill has not been routed through the PGA for NOC.CBIC e-Sanchit mandatory document requirement · document codes 0010dc, 0030dc, 0110dc
- 3If the consignment is old or refurbished equipment, confirm it appears on the permitted list published 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 assuming that a CDSCO registration covering a related needle category extends automatically to the specific sub-type being imported. G.S.R. 102(E) conditions require registration to match the precise device description; a mismatch — even within the same heading — results in consignment detention at the port and potential confiscation under the Drugs and Cosmetics Act, 1940. Verify the device description on the CDSCO certificate against the commercial invoice line item before shipment.