Global Medical Device Regulations and Safety: Navigating FDA, CE, KFDA, and Privacy Compliance
Global Medical Device Regulations and Safety: Navigating FDA, CE, KFDA, and Privacy Compliance Abstract As the global healthcare industry evolves with innovative medical devices and Software as a Medical Device (SaMD) solutions, the importance of regulatory compliance and data security grows exponentially. This article provides a comprehensive comparison of FDA (U.S.) , CE (EU) , and KFDA (Korea) certification processes. It also analyzes SaMD-specific regulatory frameworks and examines key global data privacy laws, such as GDPR and HIPAA , that influence the approval and deployment of medical devices in clinical practice. Understanding these regulatory landscapes is vital for manufacturers, clinicians, health-tech entrepreneurs, and investors seeking safe and profitable entry into international markets. 1. Introduction The global medical device market is expected to reach over USD 700 billion by 2030 , driven by technological advances such as AI diagnostics , wearable b...