Import of medical devices requires CDSCO licensing, standards conformity under Rule 7, and port-level drug controller verification. Import of medical devices including surgical and medical examination gloves requires a CDSCO license: Class A and B from 01.04.2023 and Class C and D from 01.10.2023. All Bills of Entry must conform to Rule 7(1) standards hierarchy (BIS, then ISO/IEC or pharmacopeia, then validated manufacturer standards) and comply with Rule 44 before clearance. Consignments must be referred to the Assistant Drug Controller (I) at the port for verification prior to customs clearance.
Cases where this provision is explicitly mentioned in the judgment/order text; may not be exhaustive. To view the complete list of cases mentioning this section, Click here.
Provisions expressly mentioned in the judgment/order text.
Import of medical devices requires CDSCO licensing, standards conformity under Rule 7, and port-level drug controller verification.
Import of medical devices including surgical and medical examination gloves requires a CDSCO license: Class A and B from 01.04.2023 and Class C and D from 01.10.2023. All Bills of Entry must conform to Rule 7(1) standards hierarchy (BIS, then ISO/IEC or pharmacopeia, then validated manufacturer standards) and comply with Rule 44 before clearance. Consignments must be referred to the Assistant Drug Controller (I) at the port for verification prior to customs clearance.
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