Regulatory oversight of patient safety in medical devices

Abstract

Introduction: The progressively growing number of patients who depend on medical devices and in vitro diagnostic technologies to improve, maintain, and sustain health1, results not only in enhanced benefits in healthcare, but also in a great need for robust market regulation to safeguard patients. This has led to a notable shift in focus towards a proactive and sustainable approach in enhancing patient safety.

Aims: ▪ To identify gaps in medical device regulatory science where patient’s safety may not be sustained ▪ To develop a regulatory framework that would provide a strategic oversight approach to post-market surveillance and vigilance activities to ensure long-term patient safety