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2018 (12) TMI 1791

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....Act, 2009/Medical Devices Rules, 2017 :- Sl. No. Description of Goods Law under which registration required (1) (2) (3)       01 Auto Hematology Analyzer Medical Devices Rules, 2017/BIS       02 Semi-Automatic Chemistry Analyzer Medical Devices Rules, 2017/BIS       03 LED Surgical Light BIS       04 Digital Forehead Thermometer Legal Metrology Act, 2009/Import Policy       05 Picture Display BIS 2. As the appellants had not fulfilled the above requirements, the adjudicating authority vide Order-in-Original No. 10/2018, dated 29-1-2018 confiscated....

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....lsory Registration Order under BIS. She referred to the description of the product and submitted that the said requirement of registration under BIS is applicable only to LED Lamps for General Lighting. The certificate is required for Self-Ballasted LED Lamps used for General Lighting Services, whereas, the appellants have imported LED Surgical Light. She referred to the Compulsory Registration Order for the item IS 16102 - 1 [2012] and submitted that the Indian Standard Safety requirements provide that such Self-Ballasted LED Lamps are used for domestic and similar General Lighting purposes. That the items imported by the appellants are medical equipments, in the nature of Surgical LED Lamps, which are used for surgical purposes in hospita....

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....goods cannot sustain. 7. The Learned Authorised Representatives Shri L. Nanda Kumar supported the findings in the impugned order. He argued that the appellants having violated the conditions and, therefore, goods have been correctly detained by the officers. 8. Heard both sides. 9. The issue is with regard to non-compliance of requirements contained in BIS/Legal Metrology Act, 2009/Medical Devices Rules, 2017. The description of the goods as per bill of entry dated 24-8-2017 shows 53 items out of which major part of the items are Medical Equipments. The five items, which are shown in the table above have been [detained] by Customs officers alleging non-fulfilment of conditions of BIS/Legal Metrology....

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....ation Order of BIS is incorrect. 12. The appellants have brought forth the difference between Clinical Thermometer and Digital Forehead Thermometer. As per Import Policy, Clinical Thermometer requires certificate under BIS/Legal Metrology Act, 2009. Clinical Thermometer is of two types and is different from Digital Forehead Thermometer. As per the Clinical Thermometers (Quality Control) Order, 2001, dated 9-11-2001, the restrictions are applicable only to Clinical Thermometer, which are in the nature of Solid Stem Type and Enclosed-Scale Type. It does not cover Digital Forehead Thermometer. Therefore, confiscation of these goods alleging violation of the said Acts cannot sustain. 13. The appellants have also....