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Philippines Proposes a Formal FDA Framework for Medical Device Clinical Investigations and IVD Performance Studies

The Philippine FDA is consulting on a draft Administrative Order that would establish a more complete regulatory framework for medical device clinical investigations and IVD clinical performance studies, including sponsor and CRO licensing, ethics review, FDA study approvals, safety reporting, and inspections. The draft remains under consultation and may change before final issuance.

By MedTech Alice

Published

The draft would create a more complete clinical-study pathway

The Philippine Food and Drug Administration is consulting on a draft Administrative Order covering Clinical Investigation of medical devices and Clinical Performance Studies of in vitro diagnostic medical devices.

The Center for Device Regulation, Radiation Health and Research had already been developing this framework through stakeholder consultations in 2023. The current draft brings the major regulatory elements into one proposed system rather than leaving device research requirements spread across separate authorization and operational processes.

The draft remains under consultation and may change before final issuance.

Under the proposed rules, sponsors and Contract Research Organizations conducting covered studies in the Philippines would be expected to hold an FDA License to Operate.

This would extend the regulatory framework beyond the investigational product and study protocol to the organizations responsible for planning, managing, and conducting the study.

Study start would depend on both ethics review and FDA authorization

The proposed framework introduces specific FDA approval pathways for covered studies.

Available public summaries of the draft indicate that studies involving Class B, C, and D medical devices and IVD medical devices would require the applicable Clinical Investigation Approval or Clinical Performance Study Approval before initiation.

Approval from an accredited Ethics Committee would also be required.

This creates two distinct gates that sponsors need to account for in study planning: ethical review and FDA authorization.

Oversight would continue after study authorization

The draft addresses more than study initiation. It also sets expectations for the importation and labelling of investigational devices, safety reporting, device-deficiency reporting, annual progress reports, protocol amendments, study suspension or termination, and FDA inspection.

For sponsors and CROs, this means the proposed framework would connect approval, study conduct, safety oversight, documentation, and inspection within one regulatory lifecycle.

Medical device investigations and IVD performance studies should not be treated as identical

The draft covers both conventional medical devices and IVDs, but it uses different study concepts for the two categories.

Medical devices are addressed through Clinical Investigation, while IVDs are addressed through Clinical Performance Study. Companies using one global clinical SOP across multiple device types should therefore check whether their current document sets and responsibilities distinguish the two appropriately.

The proposed framework is also intended to align Philippine requirements more closely with regional and internationally recognized clinical-study expectations.

What companies can examine now

  • Identify planned Philippine medical device clinical investigations and IVD clinical performance studies over the next one to two years.
  • Check whether the current sponsor and CRO model could support a Philippine FDA licensing requirement.
  • Build both Ethics Committee review and FDA study authorization into future study-start timelines.
  • Review whether safety reporting, device-deficiency reporting, annual progress reporting, and protocol-amendment processes can support the proposed Philippine requirements.
  • Assess whether current global clinical-study agreements clearly assign responsibility for local regulatory submissions and ongoing compliance.

The draft does not yet establish final legal requirements. Its immediate value is that it shows the regulatory structure the Philippine FDA is considering: licensed study organizations, ethics approval, FDA authorization, GCP/GSP-aligned conduct, ongoing safety oversight, and inspection.

Sources

  1. Primary official sourceDraft for Comments — Rules and Regulation on the Conduct of Clinical Investigation of Medical Devices and Clinical Performance Studies of In-Vitro Diagnostic (IVD) Medical DevicesPhilippine Food and Drug Administration
  2. Supporting sourceFDA Annual Report 2023Philippine Food and Drug Administration
  3. Supporting sourceCenter for Device Regulation, Radiation Health and Research — External ServicesPhilippine Food and Drug Administration