Digital Health Framework
FDA Philippines · CDRRHR · Draft MDSW Circular 2025 · ASEAN AMDD
Overview
The Philippines is in the process of establishing a formal regulatory framework for Medical Device Software (MDSW), including Software as a Medical Device (SaMD). As of mid-2025, the primary instrument is a draft FDA circular released for public comment.
Current Regulatory Status
| Product Type | Current Status |
|---|---|
| SaMD (standalone software with medical purpose) | Draft MDSW circular — pending finalisation (as of 2025) |
| SiMD (software embedded in hardware device) | Regulated as part of the hardware device dossier |
| Mobile medical applications | Assessed case-by-case pending MDSW finalisation |
| IVD software | Excluded from MDSW scope — separate IVD framework pending |
| Administrative / workflow software with no medical purpose | Not a medical device |
Until the MDSW circular is formally in force, contact CDRRHR directly for guidance on software-based device applications.
Draft MDSW Circular — Key Provisions
The draft circular (released May 2025, public comment deadline July 2025) proposes:
Definitions
- MDSW (Medical Device Software): Software intended to be used, alone or in combination, for a purpose as defined for a medical device
- SaMD: Software that is itself a medical device — not embedded in hardware
- SiMD: Software that is part of a hardware medical device and controls or interacts with the hardware
Classification
MDSW is classified using the standard ASEAN AMDD Class A–D framework, with classification driven by:
- The significance of information the software provides (drives clinical decision vs. displays information)
- The patient population (critical care, life-sustaining vs. general wellness)
- The severity of harm if the software malfunctions or provides incorrect output
Application Process
| MDSW Class | Application Type |
|---|---|
| Class A | CMDN via FDA eServices Portal |
| Class B, C, D | CMDR — full ASEAN CSDT submission |
The technical documentation requirements for MDSW submissions include:
- Software description and intended medical purpose
- Software architecture and design documentation
- Software development lifecycle (SDLC) documentation — IEC 62304 alignment
- Verification and validation (V&V) test reports
- Cybersecurity risk assessment
- Post-market surveillance plan for software (including update management)
AI/ML-Based Devices
AI and machine learning software that can adapt or change its behaviour after deployment (sometimes called "adaptive AI") receives additional scrutiny:
- The draft circular notes that adaptive AI requires consideration of how continuous learning affects safety and performance
- Changes to the algorithm through learning may constitute a significant change requiring variation approval
- Manufacturers of adaptive AI software should define boundaries of acceptable algorithm change in their technical documentation
ASEAN Alignment
Philippines MDSW regulation is being developed in alignment with the ASEAN Medical Device Directive and IMDRF principles for SaMD. This means:
- ASEAN NRA reliance pathway will apply to approved MDSW — a device approved by another ASEAN NRA can use the abridged 30-day pathway
- ASEAN CSDT format applies to Class B/C/D MDSW
Cybersecurity
Cybersecurity requirements are expected to be included in the finalised MDSW circular. Manufacturers of connected software devices should prepare:
- Threat modelling documentation
- Secure design architecture description
- Vulnerability management and patch/update procedures
- Post-market cybersecurity monitoring plan
Preparing for MDSW Regulation
For companies with SaMD or MDSW products targeting the Philippines market:
- Monitor CDRRHR announcements for finalisation of the MDSW circular
- Subscribe to FDA Philippines circulars at fda.gov.ph
- Prepare software documentation (IEC 62304, risk management, V&V) in advance — these will be required regardless of the final circular text
- For current applications, engage CDRRHR for case-specific guidance on how to handle software components