Regenerative medicine (RM) is transforming modern healthcare due to its potential to repair or replace damaged tissues and organs, rather than merely managing the symptoms of ailments or diseases that cause this damage. This field includes treatment options in the form of stem cell therapies, tissue engineering, and gene editing technologies such as Clustered Regularly Interspaced Short Palindromic Repeats (“CRISPR”), all of which hold significant promise in addressing chronic and previously untreatable diseases. For countries in the Global South, particularly Malaysia, RM presents both opportunities and ethical challenges. This chapter examines Malaysia’s evolving position in RM, tracing the country’s development through government investments, research infrastructure, private sector engagement, and the growing medical tourism market. This chapter critically explores the ethical and regulatory implications surrounding consent, equity, commercialization, and cultural-religious sensitivities, all of which intersect with regulatory gaps and enforcement challenges. By highlighting the regulatory frameworks and existing guidelines relevant to stem cell and gene therapy, this chapter illustrates the complexities of ensuring patient safety, promoting responsible research, and balancing innovation with public trust. In doing so, the analysis offers broader insights for developing nations navigating similar concerns. Ultimately, this chapter argues that Malaysia’s path forward lies in harmonizing international best practices with local ethical norms, strengthening governance mechanisms, and cultivating inclusive and culturally sensitive approaches to biomedical innovation.