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NHS IOC StandardsNational Highway Institute Interactive Virtual ClassroomStandards Guide2016 1Table of Contents 1. Introduction....................................................................................................................
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NHI IVC standards refers to the requirements and guidelines set by the National Health Insurance for In-Vitro Diagnostic Devices.
Manufacturers and distributors of in-vitro diagnostic devices are required to file NHI IVC standards.
NHI IVC standards can be filled out by providing information on the device, its intended use, performance characteristics, and quality control measures.
The purpose of NHI IVC standards is to ensure the safety, effectiveness, and quality of in-vitro diagnostic devices available in the market.
Information that must be reported on NHI IVC standards includes device specifications, performance data, risk assessment, and quality management system.
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