# Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access
## 5 Comparison and Global Challenges of Medical Device Regulations
### Japan's Medical Devices Lag: A Global Challenge in the Medical Devices' Market  
The medical device lag in Japan is a current global challenge. It refers to delays in the approval and adoption of new medical devices, stemming from various regulatory processes and other factors between Japan and the EU/USA [11]. Initially, this lag was substantial, reaching nearly 3 years in the early 2000s [18]. However, efforts have been undertaken to address this issue, resulting in gradual improvements over time. This phenomenon can occur at multiple stages, including pre-market approval, post-market surveillance or reimbursement processes [77]. Medical device lag stems from several key factors, including stringent regulatory frameworks that vary between countries. While these standards are crucial for patient safety, they can also lead to delays in approving new and innovative medical technologies [78]. Another significant contributor to medical device lag is the increasing complexity of modern medical devices [19]. As technology advances, devices become more intricate, incorporating sophisticated functionalities and materials. This complexity poses challenges to existing regulatory systems, which must adapt and expand their evaluation processes to adequately assess these advanced technologies. Consequently, the time required for regulatory approval and market entry often extends due to the need for more thorough evaluations and assessments [10; 78]. Furthermore, global harmonization issues compound medical device lag. Variations in regulatory requirements across different countries create barriers that hinder the simultaneous global introduction of new devices. Although there is an ongoing initiative that aims to promote the convergence and alignment of regulatory practices, achieving full harmonization remains an ongoing challenge [79]. The impact of medical device lag is multifaceted. Firstly, it limits patient access to innovative and potentially life-saving medical technologies. Delays in the approval process \begin{table}
\begin{tabular}{c c c c} \hline \hline
**Region** & **Europe** & **USA** & **Japan** \\ \hline \multirow{4}{*}{**Authority**} & European Commission (Medical Device Coordination Group) & United States Food and Drug Administration (Center for Devices and Medical Devices and Medical Devices Agency) & Ministry of Health, Labour and Welfare \\  & Notified Bodies & Devices and Pharmaceutical Authorities & Pharmaceuticals and Medical Devices Agency \\  & European Medicines Agency & Radiological Health) & Devices Agency \\ \hline \multirow{2}{*}{**Regulation**} & \multirow{2}{*}{Regulation (EU) 2017/745} & Federal Food, Drug and Cosmetic Act de 1938 and subsequent amendments & Pharmaceuticals and Medical Devices Act \\ \hline \multirow{2}{*}{**Classification**} & Class I, Isp, Imf, Irs, IIa, IIb and III & Class I, II and III & Class I, II, III and IV \\  & Based on Their Intended Purpose and Intrinsic Risk & Based on the Level of Risk They Pose to Consumers & Based on the Level of Risk Posed by the Device \\ \hline \multirow{2}{*}{**Identification System**} & \multirow{2}{*}{Unique Device Identification} & \multirow{2}{*}{Unique Device Identification} & \multirow{2}{*}{Japan Medical Device Nomenclature} \\ \hline \multirow{4}{*}{**Pre-Market**} & Declaration of Conformity & 510(k) & \\  & Conformity Assessment & Special Controls & Minister’s Approval \\  & Conducted by a Notified Body & Pre-Market Approval & (Review by Pharmaceuticals and Medical Devices Agency) \\ \hline \multirow{2}{*}{**Post-Market**} & \multirow{2}{*}{Post-Market Surveillance Report} & Medical Device Reporting & Regulatory Oversight and Revision \\  & & 522 studies & Risk Management System \\ \cline{1-1}  & Periodic Safety Reports & Pos-Approval Studies & Periodic \\ \hline \hline \end{tabular}
\end{table} 
Table 4: Comparison of medical devices’ legislation between regions. mean that patients may have to wait longer for new treatments that could significantly improve their health outcomes.