Rubber contraceptives, male (condoms)
Male rubber contraceptives (condoms, sheath contraceptives)
HSN 4014 10 10 (Rubber contraceptives, male — condoms) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as a notified medical device listed in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Import is conditional on CDSCO registration and compliance with all conditions specified in that notification.
- Registration certificate from CDSCO
- Certificate of analysis from CDSCO
- Batch release certificate from CDSCO
- 1Obtain CDSCO registration for the condom product as a notified medical device under G.S.R. 102(E) dated 11-02-2020. The registration must be valid and in force at the time of filing the bill of entry; imports from an unregistered foreign manufacturer are not permitted under the notification conditions.G.S.R. 102(E) dated 11-02-2020 issued by Ministry of Health and Family Welfare
- 2Upload all three mandatory documents in e-Sanchit before the bill of entry is presented for out-of-charge: Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc). The proper officer verifies these documents for PGA-facilitated bills not routed through the PGA for NOC.CCR mandatory-document requirement; document codes 0010dc, 0030dc, 0110dc
The most common error on this tariff line is uploading the CDSCO registration certificate alone and neglecting the batch-level documents — the Certificate of Analysis (0010dc) and the Batch Release Certificate (0030dc) are shipment-specific and must be contemporaneous with the consignment. A bill of entry presented without all three e-Sanchit uploads will not receive out-of-charge, resulting in port detention and accruing demurrage even where the CDSCO registration itself is current and valid.