Echo cardiograph
Echocardiograph, cardiac ultrasound imaging equipment
HSN 9018 19 20 (Echo cardiograph) 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) vide G.S.R. 102(E) dated 11-02-2020. The Central Pollution Control Board (CPCB) Extended Producer Responsibility authorisation under the E-Waste (Management) Rules, 2022 applies as a concurrent overlay for cardiology equipment and accessories, subject to a micro-enterprise exemption.
- Registration certificate from CDSCO
- EPR authorisation from CPCB
- Import declaration from MOHFW
- 1Obtain CDSCO registration for the echocardiograph in accordance with the conditions specified in G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare. The registration certificate must be current and available at the bill of entry; import of an unregistered medical device listed under that notification is prohibited.G.S.R. 102(E) dated 11-02-2020 · Medical Devices Rules, 2017
- 2Obtain Extended Producer Responsibility authorisation from the Central Pollution Control Board for cardiology equipment and accessories, as required under Schedule I of the E-Waste (Management) Rules, 2022. The EPR obligation does not apply to micro-enterprises as defined under the MSME Development Act, 2006; document the enterprise classification if claiming this exemption.E-Waste (Management) Rules, 2022 · G.S.R. 801(E) dated 02-11-2022
- 3If importing an old or refurbished echocardiograph, verify that the specific equipment model appears on the permitted list published under CBIC Instruction 08/2024-Customs dated 05-04-2024 and updated by CBIC Instruction 25/2024-Customs dated 28-10-2024. Refurbished equipment not appearing on that list cannot be imported and is liable to confiscation.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 overlooking the CPCB Extended Producer Responsibility authorisation as a separate clearance requirement independent of CDSCO registration. Importers who hold a current CDSCO registration but lack an EPR authorisation face consignment detention and potential monetary penalty under the E-Waste (Management) Rules, 2022; the micro-enterprise exemption must be affirmatively documented at the bill of entry and cannot be asserted retrospectively after detention.