Medical DevicesRegulatory Information ManagementRegulatory Intelligence

Regulatory Intelligence for Medical Device Clinical trials


Booth: 428

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.

Other product: Regulatory Intelligence

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