The regulatory landscape plays a critical role in meeting patient safety requirements and developing the right products for purpose. Each global authority dictates their processes for the clearance/approval of medical products and the continued surveillance of these products in regions where they are marketed. It is important to understand what activities are required to support a regulatory package to demonstrate safe and effective use. The goal of this chapter is to explore considerations for maintaining user centricity within the regulated industries of medical devices, pharmaceuticals, and biologics, discussed from the regulatory purview and perspective. This includes understanding the role of a regulatory body, how regulatory science is used to address patient safety, considerations for human factors/usability engineering in different regions, and how developers can apply a robust, patient-centric process while ensuring timely delivery of products to market.