Cannulae
Medical cannulae for surgical or clinical use
HSN 9018 39 30 (Cannulae) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under G.S.R. 102(E) dated 11-02-2020, issued by the Ministry of Health and Family Welfare (MOHFW) under the Medical Devices Rules, 2017. CDSCO registration of the device and the foreign manufacturer is a pre-import requirement, and three mandatory documents must be uploaded in e-Sanchit before out-of-charge is granted.
- Registration certificate from CDSCO
- Batch release certificate from CDSCO
- Certificate of analysis from manufacturer
- 1Obtain CDSCO registration for the cannula as a medical device listed under G.S.R. 102(E) dated 11-02-2020. The registration must cover both the device and the foreign manufacturing facility; importing from an unregistered facility is not permitted under the conditions notified by the Ministry of Health and Family Welfare.G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017 · MOHFW notification
- 2Upload all three mandatory documents in e-Sanchit before the bill of entry reaches 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 will verify these uploads on PGA-facilitated bills.CDSCO CCR documentation requirement · e-Sanchit document codes 0010dc, 0030dc, 0110dc
- 3If the cannulae are sought to be imported in an old or refurbished condition, verify that the specific equipment falls within the permitted list under CBIC Instruction 08/2024-Customs dated 05-04-2024, as amended by Instruction 25/2024-Customs dated 28-10-2024. Refurbished devices not on that list are not eligible for import.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 shipping a consignment before the foreign manufacturer's facility registration with CDSCO is confirmed as active and covering the specific cannula type. A valid CDSCO device registration held by the Indian importer does not substitute for facility registration — the two are distinct requirements under G.S.R. 102(E), and a facility-registration gap results in detention at port, with demurrage and ground rent accruing until regularisation or re-export.