Indonesia’s Ministry of Health has published its first guidance written specifically for software medical devices. The guidance explains how developers can obtain a marketing license and covers three groups – standalone software (SaMD), software that runs or controls a physical device (SiMD), and AI- and machine learning-enabled devices.
Software only counts as a medical device if its output supports diagnosis, monitoring, treatment decisions, or another clinical purpose. Administrative and data-storage tools are excluded.
AI products face the strictest new requirement. An imported AI device used for moderate- to high-risk work, such as diagnosis, screening, or clinical decision support, must be validated locally. The same applies to any model retrained on data from Indonesian patients. Testing can take place at hospitals, universities, accredited labs, or ministry facilities. It can run alongside the license application, but results are due within a year after the license is granted.
The decree also sets rules for software changes. A change that affects intended use, core function, or clinical performance requires a new registration. Updates with lower impact can be filed as amendments to the existing license.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.