A Good Paper on Comparison of Approaches to Regulation of Different Countries

The paper titled "Ensuring Medical Device Effectiveness and Safety: A Cross-National Comparison of Approaches to Regulation" by Kramer et al. provided a systematic and in-depth comparisons of regulation of the US, EU, Japan, and China. The comparisons are based on six key features of device regulation:

1. Regulatory Authority
2. Pre-Market Evaluation
3. Adverse Event Reporting
4. Quality System Regulation
5. Post-Approval Studies
6. Post-Market Regulation Actions

Emerging strategies of post-approval surveillance were also discussed such as unique device identifier (UDI) system.