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of <h1>Imported medical devices must meet Rules 2017 standards and Rule 7(1) and Rule 44; CDSCO licenses mandatory by 01.04.2023/01.10.2023</h1> Public notice requires that all imported medical devices, including surgical and medical examination gloves (classified as Class B and Class A respectively), comply with the Medical Devices Rules, 2017 and related definitions; CDSCO import licenses are mandatory from 01.04.2023 for Class A/B and from 01.10.2023 for Class C/D. Imports must meet standards under Rule 7(1) (BIS, ISO/IEC, pharmacopeia or validated manufacturer standards) and Rule 44 before clearance. All Bills of Entry for medical devices must be referred to the port Assistant Drug Controller (I) for verification prior to customs clearance.
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