The Food and Drug Administration of the Philippines (PFDA) has circulated a revised draft FDA Circular entitled "Regulatory Guidelines for Medical Device Software (MDSW)", proposing updated requirements for MDSW, including Artificial Intelligence-enabled MDSW (AI-MDSW). Supplementing Administrative Order No. 2018-0002, which aligns with the ASEAN Medical Device Directive (AMDD), the draft provides guidance on software qualification, risk classification, initial and renewal authorization, and lifecycle regulatory controls, including cybersecurity and post-market monitoring, in accordance with International Medical Device Regulators Forum (IMDRF) principles.
Key Proposed Regulatory Requirements
1. Scope and Software Qualification
The draft covers the following:
- Software as a Medical Device (SaMD) – also known as Standalone Software, it is software intended to perform one or more medical purposes without being part of a hardware medical device.
- Software in a Medical Device (SiMD) – software that is embedded within and controls the function of a physical medical device.
- AI-enabled Medical Device Software (AI-MDSW) – software intended for medical purposes that utilizes AI techniques, to analyze data, generate predictions, classifications, or recommendations, or support or automate clinical decision-making.
It also clarifies exclusions from MDSW product authorization, subject to the software’s intended purpose and functions, including:
- General wellness and lifestyle applications (e.g., fitness tracking, diet logging, and sleep monitoring)
- Administrative and healthcare management systems
- Electronic health records and communication platforms without clinical analysis or recommendation functions
- Certain Clinical Decision Support Systems (CDSS) that allow healthcare professionals to independently review, understand, and validate the basis of recommendations without replacing, automating, or overruling their clinical judgment.
Software classified as in vitro diagnostic (IVD) medical devices and software intended to be used as part of or in conjunction with IVDs are excluded from the draft Circular.
2. Risk Classification and Product Authorization
The draft introduces a risk-based classification framework for MDSW, assigning devices to Classes A-D based on their intended purpose, the significance of information provided for healthcare decision-making, and the severity of the healthcare condition, in alignment with IMDRF guidance. Further details on the classification criteria and examples are provided in Annex A of the draft Circular.
| State of Healthcare Situation or Condition | Information Provided by MDSW to Healthcare Decision | ||
| Treat or Diagnose | Drive Clinical Management | Inform Clinical Management | |
| Critical | D | C | B |
| Serious | C | B | A |
| Non-serious | B | A | A |
The draft also establishes classification rules for embedded software, separately marketed software that acts as accessories, systems that involve multiple interconnected platforms (e.g., mobile applications, wearable devices, or desktop interface), and software that forms part of a multi-component system, considering their intended purposes and individual software functions, as outlined in Section VI.
Based on the assigned risk classification, MDSW will require the following product authorization:
| Risk Class | Required Authorization |
| Class A | Certificate of Medical Device Notification (CMDN) |
| Classes B, C, and D | Certificate of Medical Device Registration (CMDR) |
Covered establishments must hold a valid FDA License to Operate (LTO) before applying for product authorization. For initial applications, Class A MDSW will follow the notification process through the FDA eServices Portal System, while Classes B, C, and D will undergo registration through email submission to the PFDA. Application procedures are specified in Section VI.D and Annexes F and G, while documentary requirements are provided in Annexes B, C, and D.
Eligible MDSW may also qualify for abridged processing under FDA Circular No. 2022-008, subject to applicable conditions and documentary requirements.
3. Technical Documentation and AI-Specific Requirements
The draft introduces additional technical documentation requirements for MDSW, covering initial registration and renewal applications. The key requirements are summarized below.
| Application / Device Type | Key Documentation Requirements |
| Initial Notification (Class A) |
Device description, declaration of conformity, and labelling. |
| Initial Registration (Classes B-D) |
Executive summary, device description (software architecture, system diagrams, operating environment, interoperability, software specifications and features), design verification and validation (software lifecycle, test plans and protocols, test reports, traceability matrix, software problem resolution, usability, cybersecurity), risk management, labelling, manufacturing information, Essential Principles checklist, post-market surveillance, and declaration of conformity. |
| Additional Clinical Evidence (Classes C-D) | Clinical Evaluation Report (CER), performance evaluation, literature and/or clinical study data, and real-world evidence (if available). |
| AI-MDSW Initial Registration (Additional Requirements) |
Algorithm description, data flow, model validation, performance metrics, bias and AI-specific risks, statement that AI technology is incorporated into the device, and Predetermined Change Control Plan (PCCP) and model updates, as applicable. |
| Renewal (All Classes) |
Screenshots of user interface, system architecture diagram, labelling, post-market performance safety, software lifecycle and changes, updated risk management summary, and cybersecurity report. |
| AI-MDSW Renewal (Additional Requirements) |
AI performance monitoring report (as applicable), model versioning summary, and PCCP and model updates for MDSW already registered without submitting these during initial registration. |
Implementation and Regulatory Impact
The Circular remains in draft form and is not yet effective. No specific transition period is provided in the draft.
Once finalized, the guidelines may require manufacturers and market authorization holders to reassess their MDSW classifications, review existing technical documentation, and strengthen clinical, cybersecurity, and post-market evidence.
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References
- Draft FDA Circular – Regulatory Guidelines for Medical Device Software (MDSW)
- Administrative Order No. 2018-0002 – Guidelines Governing the Issuance of an Authorization for A Medical Device Based on the ASEAN Harmonized Technical Requirements
- FDA Circular No. 2022-008 – Abridged Processing of Application for Registration of Medical Devices Approved by the National Regulatory Authority of Any ASEAN Member Country