Medical equipment – Philippines

The proposed FDA Circular provides guidelines on the maintenance of importation and/or distribution records and the reporting of product complaints, adverse events (Aes), and field safety corrective actions (FSCAs) for medical devices. It applies to all registered medical devices and in vitro diagnostic (IVD) medical devices placed on the Philippine market. The Circular defines the responsibilities of Marketing Authorization Holders (MAHs) and dealers in maintaining traceability records and supporting post-market surveillance (PMS). The Circular also sets clear criteria for determining reportable AEs and FSCAs. It establishes standardized reporting formats, timelines, and submission procedures for AE and FSCA notifications to the FDA. The Circular provides guidance on complaint handling, record retention, and follow-up reporting. It further outlines procedures for FSCA initiation, implementation, and closure, including FDA review and concurrence. The measure aligns national post-market requirements with the ASEAN Medical Device Directive (AMDD), particularly Annex 5 on the Post-Marketing Alert System.