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March 1, 2025
Approximately 5 minutes
Philippines SaMD Registration: Regulatory Framework and Technical Standards
Software as a Medical Device (SaMD) Registration in the Philippines
The registration of stand-alone Software as a Medical Device (SaMD) in the Philippines is governed by the new regulatory framework, primarily Administrative Order No. 2018-0002. This order specifically includes software in the legal definition of a medical device (Clause IV, Sec. 15), meaning SaMD must undergo the required pre-market approval process through the Center for Device Regulation, Radiation Health and Research (CDRRHR).
Classification and Conformity Assessment
SaMD is subject to a risk-based classification system (Low to High Risk) following the guidance of the ASEAN Medical Devices Directive (AMDD). The classification dictates the required conformity assessment:
- Certificate of Medical Device Notification (CMDN): Required for lower-risk SaMD (e.g., Class A).
- Certificate of Medical Device Registration (CMDR): Required for higher-risk SaMD (e.g., Classes B, C, D).
The intended use of the software determines its classification. For instance, an irregular heart rate monitoring app is typically considered a medical device, while a general fitness or wellness app is not.
Technical Documentation and Compliance Standards
Registration requires comprehensive technical documentation, which must align with international standards specific to software life cycles and safety, in addition to the ASEAN Common Submission Dossier Template (CSDT) requirements.
| Standard | Focus Area |
|---|---|
| IEC 62304:2006 | Software Life Cycle Processes for development and maintenance. |
| IEC 82304-1 | Safety and Security of Health Software (specific for stand-alone SaMD). |
| IEC 60601-1 (Sec. 14) | Applies to embedded software in hardware devices. |
| IEC 81001-5-1 | Health software and health IT system security/cybersecurity requirements. |
| IEC 62366-1 | Usability Engineering (man-machine interface ergonomics). |
The dossier must include standard technical data, Design Validation and Verification Reports, and detailed specifications of the software.
Data Privacy and License Maintenance
- Data Privacy: SaMD manufacturers must ensure compliance with the Data Privacy Act of 2020 (RA 10173), which requires robust protection of user data and adherence to the National Privacy Commission's guidelines.
- Importing: Since SaMD is typically downloaded without physical import, the customs clearance requirements supervised by the local License Holder do not apply unless the software is physically distributed (e.g., on a USB drive).
- License Maintenance: Registrations require payment of an Annual Retention Fee. Approval must be obtained for any changes to the software that affect the original registration, especially updates to the labeling and Instructions For Use (IFU).
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