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Category: Clinical Evaluation (Clinical Trial, CER, etc.)

Tech Guide for Comparing the Same Variety of IVD Exempted from Trials (Draft)

November 22, 2018

Technical Guideline for Comparing the Same Variety of In-vitro Diagnostic Reagents Exempted from Clinical Trials (Draft)

Guidelines for Clinical Trials of In Vitro Diagnostic Reagents (Draft)

November 22, 2018

Medical Device Clinical Trial Design Guideline

January 8, 2018

Requirements for Clinical Evaluation of IVD Exempted from Trial (Draft)

November 8, 2017

Basic Requirements for Clinical Evaluation Materials of IVD Exempted from Clinical Trial (Draft)

Good Clinical Practice for Medical Device

March 23, 2016

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