Keywords: Real-world data, Real-world evidence, Regulatory decision-making
In medical product development, there has been an increased interest in utilizing real-world data (RWD) which have become abundant owing to advances in biomedical science, information technology and engineering. High-quality real-world data may be utilized to generate real-world evidence (RWE) for regulatory decision-making. This presentation will focus on practice and perspectives on the use of RWD and RWE in regulatory decision-making for medical devices, illustrated with examples from our pre-market reviews.