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Clinical Evaluation


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Good Clinical Practice For Medical Device (NMPA Decree 28, 2022) (May 1, 2022)

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Registration Review Guideline Of The Requirements For Submission Of Clinical Trial Data Of Medical Devices (November 25,2021)

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Medical Device Clinical Trial Institution Conditions And Record Management Measures (March 9, 2022)

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Technical Guideline Of Clinical Evaluation Report For Medical Device Registration (Final)

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Technical Guidelines For The Use Of Real World Data In Clinical Evaluation Of Medical Devices (Trial)

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Technical Guideline For Clinical Evaluation Of Pulse Oximeter Equipment

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Technical Guidance On Clinical Evaluation Of Medical Devices Part 3 Clinical Trial (Draft)

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Technical Guidance On Clinical Evaluation Of Medical Devices Part 2 Clinical Evaluation (Draft)

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Technical Guidance On Clinical Evaluation Of Medical Devices Part 1 Key Definitions And Concepts (Draft)

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Guideline For Comparing The Same Variety Of In-vitro Diagnostic Reagents Exempted From Clinical Trials (draft)

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Guideline For Clinical Trials Of In Vitro Diagnostic Reagents (draft)

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Decree 25 Good Clinical Practice For Medical Devices

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