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  Indian J Med Microbiol
 

Figure 5: Clinical investigation of medical device and clinical performance evaluation process of new IVDMD. CDSCO: Central Drug Standard Control Organisation; CI: Clinical Investigation; CIP: Clinical Investigation Plan; CLA: Central Licensing Authority; CPE: Clinical Performance Evaluation; CPEP: Clinical Performance Evaluation Plan; FIH: First in Human; GCP: Good Clinical Practice; IVDMD: In vitro Diagnostic Medical Device; MD: Medical Device; SUSAR: Suspected Unexpected Serious Adverse Reaction

Figure 5: Clinical investigation of medical device and clinical performance evaluation process of new IVDMD. CDSCO: Central Drug Standard Control Organisation; CI: Clinical Investigation; CIP: Clinical Investigation Plan; CLA: Central Licensing Authority; CPE: Clinical Performance Evaluation; CPEP: Clinical Performance Evaluation Plan; FIH: First in Human; GCP: Good Clinical Practice; IVDMD: <i>In vitro</i> Diagnostic Medical Device; MD: Medical Device; SUSAR: Suspected Unexpected Serious Adverse Reaction