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Special Device Types

CDRRHR · DOH AO 2018-0002 · Draft MDSW Circular 2025

Software as a Medical Device (SaMD) / Medical Device Software (MDSW)​

Regulatory Status​

As of 2025, the Philippines FDA released a draft circular on Medical Device Software (MDSW) for public comment (comment deadline: July 2025). The draft establishes:

  • Definitions distinguishing Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD)
  • An ASEAN AMDD-aligned risk classification approach for MDSW
  • Application process aligned with the CMDN/CMDR framework

Pending finalisation: Until the MDSW circular is finalised and in force, software devices are assessed on a case-by-case basis by CDRRHR. Contact CDRRHR for guidance on the current status before submitting software-based device applications.

Scope Under the Draft Circular​

CategoryCovered?
SaMD (standalone software with medical purpose)Yes
SiMD (software embedded in hardware device)Yes — as part of the device dossier
IVD softwareExcluded — separate IVD framework expected
Software with no medical purpose (administrative, workflow)Not a medical device

Classification of MDSW​

Classification follows the ASEAN AMDD risk rules, with additional consideration of:

  • Significance of information provided (e.g., driving clinical decision vs. informational display)
  • Patient population (critical care vs. general wellness)
  • Severity of harm if the software fails or provides incorrect output

AI/ML-driven software that modifies its behaviour after deployment is likely to receive additional scrutiny under the draft framework.

Combination Products — Drug-Device Combinations​

Combination products (device combined with a drug) are assessed based on the principal mode of action (PMOA):

  • If the principal action is achieved by the drug: regulated as a drug by CDRRHR (CDRR center) — the device component is assessed for safety
  • If the principal action is achieved by the device: regulated as a medical device by CDRRHR — the drug component is assessed for safety

Contact CDRRHR for a product determination if the PMOA is unclear. There is no formal borderline committee as in the EU; CDRRHR issues case-by-case determinations.

In Vitro Diagnostics (IVDs)​

IVDs are currently NOT required to register in the Philippines under the existing framework (DOH AO 2018-0002). IVD products:

  • Do not require a CMDN or CMDR at present
  • May still require an LTO for the distributor/importer
  • Are subject to CDRRHR oversight for post-market safety concerns
  • Will be subject to registration requirements once the IVD framework is implemented (timeline to be confirmed)

Monitor CDRRHR announcements for updates on IVD registration implementation.

Radiation-Emitting Devices​

Radiation-emitting devices (X-ray equipment, lasers, ultrasound for diagnostic use) fall under CDRRHR's dual mandate for medical devices and radiation health:

  • Standard CMDN/CMDR registration applies based on risk class
  • Additional radiation safety assessment under the Radiation Control Act (RA 5527) may be required
  • Importation of radiation-emitting devices may require separate clearance from the Philippine Nuclear Research Institute (PNRI) for certain device types
  • Contact CDRRHR and PNRI for device-specific requirements

Custom-Made Devices​

Custom-made devices (made specifically for a named individual patient on a clinician's prescription) have reduced regulatory obligations:

  • Generally exempt from CMDN/CMDR requirement
  • The manufacturer or clinician fabricating the device must maintain a technical file
  • No commercial sale of the device is permitted under the custom-made exemption
  • The exemption does not apply to mass-produced devices adapted for individual patients (these require standard registration)

Single-Use Devices​

Single-use devices (labelled for one-time use) must carry clear single-use labelling. Reprocessing and re-use of single-use devices is not regulated under a formal framework in the Philippines, but CDRRHR may take enforcement action where reprocessing creates documented safety risks.

Sterile Devices​

Devices placed on the market in a sterile state:

  • Must include sterilisation validation data in the CSDT (Section 5 — Design Verification and Validation)
  • Sterility assurance must be demonstrated using recognised standards (ISO 11135, ISO 11137, ISO 13485)
  • Sterile packaging integrity must be validated

Implantable Devices​

Implantable devices (permanently or long-term implanted) are generally classified as Class C or D under ASEAN AMDD rules. They require:

  • Comprehensive clinical evidence (CER or clinical investigation data)
  • Biocompatibility testing per ISO 10993
  • Long-term performance data where available
  • Detailed post-market surveillance plan