ARTICLE SUMMARY:
South Korea’s Digital Medical Products Act took effect earlier this year. Now the country’s regulatory authority is working to fully implement the law, including with the release of almost a dozen regulations and guidance documents over the past two months.
Docs of the Month is a regular column highlighting key findings from Pathways’ Document Depot, a database of global medtech regulatory and policy official documents, including rules, guidances, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.
Applying established medical device and diagnostic frameworks to regulate digital health products can be a source of frustration for authorities and manufacturers alike. In many cases, regulators dedicate significant resources to finding ways (using guidance documents, enforcement exemptions, and other mechanisms) to contort or work around elements of existing statutes so they don’t unnecessarily impede innovation in software and artificial intelligence-based devices.
