Clinical Evaluation

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

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

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

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

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

Technical Guideline For Clinical Evaluation Of Pulse Oximeter Equipment

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

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

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

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

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

Decree 25 Good Clinical Practice For Medical Devices