Tissue engineering has been transformed by biomaterials-based additive manufacturing, which makes it possible to precisely fabricate intricate structures with customized characteristics. This chapter examines the opportunities, difficulties, and regulatory environment around the use of additive manufacturing in tissue engineering applications. The development and commercialization of additive manufacturing technologies based on biomaterials are significantly influenced by regulatory factors. The European Union’s Medical Device Regulation (MDR) and the FDA’s regulations for 3D-printed medical devices are only two examples of the regulatory processes and standards covered in this chapter that govern these technologies. It is important to comprehend and adhere to these rules to guarantee the safety and effectiveness of tissue-engineered products. Tissue engineering has great promise for the use of biomaterials-based additive manufacturing in the future. Innovation in this field is being driven by developments in bio-ink development, printing technologies, and materials science. The chapter covers new developments in the field, including stem cell applications in additive manufacturing, bio-fabrication of vascularized tissues, and multi-material printing. These advancements have enormous potential for producing organoids and functional tissue substitutes for use in drug testing and regenerative medicine. The book chapter provides an overview of regulatory considerations that must be carefully considered, technological developments must continue, and present obstacles must be overcome. Also, insights into the regulatory environment, potential opportunities, and difficulties related to biomaterials-based additive manufacturing for tissue engineering are provided in this chapter, which will be helpful to researchers and industry participants in this quickly developing subject.