Indonesia’s Initiatives in Implementing Medical Device Nomenclature Standards: Current Gaps with Global Standards

This paper compares Indonesia’s national medical device nomenclature standards with World Health Organization’s MeDevIS platform, which incorporates the GMDN and EMDN. Medical devices in Indonesia are governed by a hierarchical nomenclature system, outlined in the Ministerial Health Decree and dictionary for pharmacy and medical devices, known as KFA, but these systems face challenges in standardizing medical devices’ nomenclature. A desk review of existing metadata standards reveals discrepancies in metadata coverage between Indonesia’s national standards and global standards. Notably, MeDevIS includes more comprehensive metadata, such as knowledge level, reusable vs. single-use status, and intended population characteristics, which are absent in the national system. The study highlights the need for a unified, standardized nomenclature system to improve device identification throughout the medical devices’ lifecycle.