Combination products with a wide range of clinical applications represent a unique class of medical products that are composed of more than a singular medical device or drug/biological product. The product research and development, clinical translation as well as regulatory evaluation of combination products are complex and challenging. This review firstly introduced the origin, definition and designation of combination products. Key areas of systematic regulatory review on the safety and efficacy of device-led/supervised combination products were then presented. Preclinical and clinical evaluation of combination products was discussed. Lastly, the research prospect of regulatory science for combination products was described. New tools of computational modeling and simulation, novel technologies such as artificial intelligence, needs of developing new standards, evidence-based research methods, new approaches including the designation of innovative or breakthrough medical products have been developed and could be used to assess the safety, efficacy, quality and performance of combination products. Taken together, the fast development of combination products with great potentials in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.

具有广泛临床应用的组合产品代表了一类独特的医疗产品，它由多个单一的医疗器械或药物/生物产品组成。组合产品的产品研发、临床转化以及监管评估复杂且具有挑战性。本综述首先介绍了组合产品的起源、定义和名称。然后介绍了有关设备主导/监督组合产品的安全性和有效性的系统监管审查的关键领域。讨论了组合产品的临床前和临床评价。最后，阐述了组合产品监管科学的研究前景。计算建模与仿真新工具，人工智能等新技术，开发新标准、循证研究方法、包括指定创新或突破性医疗产品在内的新方法的需求已经开发出来，可用于评估组合产品的安全性、有效性、质量和性能。总之，在医疗保健领域具有巨大潜力的组合产品的快速发展为监管审查和监管科学的进步提供了新的机遇。