Instrument and apparatus for measuring blood pressure
Instruments and apparatus for measuring blood pressure
HSN 9018 90 11 (Instrument and apparatus for measuring blood pressure) 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). Legal Metrology Act, 2009 registration and product approval certificates apply as a concurrent overlay for sphygmomanometers, and refurbished or second-hand imports are governed by CBIC Instruction 08/2024-Customs and CBIC Instruction 25/2024-Customs.
- Registration certificate from CDSCO
- Legal Metrology registration from Legal Metrology
- Importer weights and measures certificate from Legal Metrology
- 1Obtain CDSCO registration for the blood-pressure measuring device 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 available at the bill-of-entry stage as a mandatory PGA clearance document.G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare
- 2Verify Legal Metrology registration and product approval certificates for sphygmomanometers (instruments for measuring arterial blood pressure), and ensure the certificate of registration of importer of weights and measures (document code 101lm1) is uploaded in e-Sanchit before out-of-charge. Sections 19, 20, and 22 of the Legal Metrology Act, 2009 and Rules 11 to 15 (Eighth Schedule) of the Legal Metrology (General) Rules, 2011 as amended govern this requirement.Sections 19, 20 and 22 of the Legal Metrology Act, 2009 · Rules 11–15, Eighth Schedule of the Legal Metrology (General) Rules, 2011
- 3If importing blood-pressure instruments in old or refurbished condition, confirm the device is listed among the equipment permitted in such state under CBIC Instruction 08/2024-Customs dated 05-04-2024 and CBIC Instruction 25/2024-Customs dated 28-10-2024. Consignments of refurbished devices not on the permitted list are liable to detention and re-export.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 treating CDSCO registration as the sole compliance gate and overlooking the Legal Metrology overlay: sphygmomanometers are measuring instruments subject to product approval and importer registration under the Legal Metrology Act, 2009, independent of the medical-device regime. A consignment with a current CDSCO certificate but no Legal Metrology registration (document code 101lm1 absent from e-Sanchit) will be held at out-of-charge; the two regimes must be satisfied in parallel, not in sequence.