Description: Managing IVD product development and clinical performance studies requires knowledge of multiple regulations and standards especially if there is an intent to commercialize an IVD in different geographies. Different countries and their relevant regulations may define an IVD product, measure risk, and specify regulatory requirements with variations. Likewise, while most of these regulations are harmonized in spirit, clinical performance studies that generate evidence of a safe and “effective” diagnostic product have different rules for stakeholder roles and responsibilities and oversight of human subject protection, data integrity and data privacy. This presentation will compare IVD product development and clinical performance studies in the United States as a point of context to compare to the NMPA in China, and ISO 20916 and IVDR in the EU.
Learning Objectives:
Upon completion, participants will be able to identify applicable regulations that define an IVD product in China, under the IVDR and in the United States.
Upon completion, participants will be able to cite regulations and pre-clinical testing responsibilities for IVD products in China, under the IVDR and in the United States.
Upon completion, participants will understand the Investigator, Sponsor/Manufacturer, and CRO responsibilities for IVD clinical performance studies with United States in comparison to China and IS0 20916/IVDR.