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10.0 Analytical sensitivity: This section should include information about the study desig...

2023-10-04T04:25:06

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(b) If the in vitro diagnostic medical device contains any of the following then descripti...

2023-09-16T05:06:09

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In vitro diagnostic medical devices for blood grouping or tissue typing (a) Subject to cl...

2023-09-09T08:54:37

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Overall synopsis of the clinical investigation A summary or overview of the clinical inves...

2023-07-11T04:32:16

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CLINICAL INVESTIGATION PLAN 1.1 General 1.1.1 Introduction This document specifies the con...

2023-07-11T04:28:48

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Regulatory and other references (a) List of International Standards, if any, complied with...

2023-07-10T11:14:58

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Metrological traceability of calibrator and control material values Where applicable, summ...

2023-06-28T06:45:53

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Analytical sensitivity: This section should include information about the study design and...

2023-06-28T06:43:50

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Manufacturing processes: Central Drugs Standard Control Organization, Ministry of Health a...

2023-06-27T05:37:10

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