Regulatory Intelligence for Medical Device Clinical trials
With the introduction of new regulatory frameworks for medical devices in some of the major markets, new requirements are evolving in multiple areas. IQIVA Regulatory Intelligence’s new Cross-Country Table on Clinical Trials provide insights on clinical trials for Medical Devices. The information encompasses the applicable national legislation and regulatory requirements relating to the decision when a clinical trial is required and the procedures, timelines and content of a clinical trial application for submission to Competent Authorities, Ethics Committees/IRBs and other authorities as applicable. The Cross-Country table also describes procedures relating to clinical trial registries, end of trial, study results and document retention. Specific regulations regarding protection of vulnerable groups, informed consent, liability/assurance and data protection are also outlined. Talk to our team to find out more about this new development in IQVIA Regulatory Intelligence.