AIRA FDA Philippines Assessment

Hi — I'm AIRA, your governance advisor at airagov.com. This assessment covers the Philippines' regulatory requirements for AI medical devices and Software as Medical Device (SaMD) under the Food and Drug Administration Philippines (FDA PH) framework. We'll assess your alignment with RA 9711 (FDA Act of 2009), FDA Circular No. 2020-013 (SaMD Guidelines), AO 2021-0012 (MDRLS), FDA Circular No. 2021-010 (Post-Market Surveillance), IMDRF CYBER 2023 (N60), ISO 14971:2019, ISO 13485:2016, and the IMDRF SaMD frameworks adopted by FDA PH for classification, clinical evaluation, and quality management. FDA PH has adopted a risk-based approach to SaMD regulation aligned with international IMDRF standards. Let's see where your organization stands. Ready to get started?