Medical devices play a crucial role in human health. These are instruments, machines or even software programs used to diagnose, treat, monitor or prevent health conditions. They are designed to help improve patients’ quality of life and range from simple items, such as thermometers, to more advanced technologies, such as pacemakers. In order to guarantee the safety and efficacy of medical devices intended for use on patients, the establishment of appropriate regulatory frameworks is crucial to ascertain whether devices function as intended, comply with safety standards and offer benefits that outweigh the associated risks. Depending on the country, different regulatory agencies are responsible for the evaluation of these products. The regulatory landscape for medical devices varies significantly across major markets, including the European Union, the United States of America and Japan, reflecting diverse approaches aimed at ensuring the safety and efficacy of medical technologies. However, these regulatory differences can contribute to a “medical device lag,” where disparities in approval processes and market entry timelines driven by strict regulatory requirements, increasing device complexity and the lack of global harmonization, result in delays in accessing innovative technologies. These delays impact patient access to cutting-edge medical devices and competitiveness in the market. This review aims to address the regulatory framework of medical devices and the approval requirements by the European Commission (EC), the Food and Drug Administration (FDA) and Pharmaceuticals and Medical Device Agency (PMDA).

Biosimilars are a new category of medicines that have revolutionized the treatment of patients with life-threatening conditions, such as cancer and autoimmune diseases. A biosimilar is a biological product that is very similar to an already approved biological medicine that is used as its reference. These medicines go through less clinical studies than their reference product and therefore the cost of their development process is significantly lower, giving patients access to them more quickly and at a more affordable price. However, due to the structural complexity and inherent degree of variability of these products, it is very difficult to develop biosimilar medicines that are exactly the same as the reference product. Thus, it is extremely important to define strict controls to guarantee that these minor differences are not clinically significant in terms of safety and efficacy. Like any other medicine, biosimilars have to go through a complex approval process, which involves a thorough assessment by regulatory authorities to ensure these products meet the necessary standards of quality, safety, and efficacy before being placed on the market. Due to their nature and complexity, the approval process of biosimilar medicines contains some unique and specific considerations. This review aims to address the regulatory framework of biosimilar medicines, their development process and the approval requirements by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).