Electro-cardiographs
Electrocardiographs, cardiac monitoring and diagnostic equipment
HSN 9018 11 00 (Electro-cardiographs) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules issued pursuant to G.S.R. 102(E) dated 11-02-2020, notified by the Ministry of Health and Family Welfare (MOHFW). The Central Pollution Control Board (CPCB) Extended Producer Responsibility authorisation under the E-Waste (Management) Rules, 2022 applies as a concurrent overlay, subject to a micro-enterprise exemption. Refurbished or old-equipment imports are further governed by CBIC Instruction 08/2024-Customs dated 05-04-2024 and Instruction 25/2024-Customs dated 28-10-2024.
- Registration certificate from CDSCO
- EPR authorisation from CPCB
- Refurbished-equipment clearance from CBIC
- 1Obtain CDSCO registration for the electrocardiograph as a medical device under 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 for verification at the bill-of-entry stage; imports without valid CDSCO registration are liable to detention and seizure.G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare Medical Devices Rules
- 2Secure Extended Producer Responsibility authorisation from the Central Pollution Control Board under Schedule I of the E-Waste (Management) Rules, 2022 before import. EPR authorisation is not required for importers qualifying as micro enterprises under the MSME Development Act, 2006; retain documentary proof of micro-enterprise status if relying on this exemption.G.S.R. 801(E) dated 02-11-2022 · Schedule I of the E-Waste (Management) Rules, 2022
- 3If importing electrocardiographs in an old or refurbished state, confirm the equipment appears on the permitted list under CBIC Instruction 08/2024-Customs dated 05-04-2024, as updated by Instruction 25/2024-Customs dated 28-10-2024. Equipment not on that list cannot be imported in a refurbished condition regardless of CDSCO registration status.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 EPR authorisation as a separate, concurrent condition independent of CDSCO registration. Importers who hold a valid CDSCO registration but have not obtained EPR authorisation remain non-compliant, and the exemption for micro enterprises is self-assessed — customs officers are authorised to require proof of MSME micro-enterprise status at the bill of entry, and an unsupported exemption claim attracts consignment detention.