This paper explores the expansion from fintech-based regulatory sandboxes to those that include medical artificial intelligence (AI) by examining their potential to foster innovation and accelerate market access while ensuring safety and compliance

especially considering how they provide a flexible framework for medical AI companies to develop and test new technologies. This work also highlights the key risks involved

including data privacy

ethical concerns

real-world validation

and regulatory consistency

and proposes strategies for mitigation. Using case studies from the United States

the United Kingdom

the European Union

Indonesia

Japan

and China

this paper illustrates how regulatory sandboxes can support AI-driven healthcare innovation. Overall

although regulatory sandboxes present several risks

they are valuable for advancing medical AI

granted that they balance innovation with robust oversight to ensure patient safety and long-term benefits.