ARTICLE SUMMARY:
In this month’s spotlight from Pathways’ Document Depot, Malaysia and the Philippines roll out policy docs that build on the decade-long project to harmonize device regulations in Southeast Asia.
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, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.
Creating a harmonized device regulatory structure that can be shared among multiple sovereign nations is a challenge. Each participating country fully implementing the structure is perhaps an even steeper climb. The 10 countries of the Association of Southeast Asian Nations (ASEAN) are (to varying degrees) deep into the second part of that effort.
