The Philippine Food and Drug Administration (FDA) has released for public comment a Draft Administrative Order that will establish the rules and requirements for conducting Clinical Investigation (CI) of Medical Devices and Clinical Performance Studies (CPS) of In-Vitro Diagnostic (IVD) Medical Devices in the Philippines.
Stakeholders are invited to submit comments on or before 25 August 2026.
The proposed regulation aims to strengthen the country’s regulatory framework by aligning local requirements with the ASEAN Medical Device Directive (AMDD) and internationally recognized standards, including PNS ISO 14155:2022 for medical devices and PNS ISO 20916:2022 for IVD medical devices.
Read the full draft here:
https://www.fda.gov.ph/draft-for-comments-rules-and-regulation-on-the-conduct-of-clinical-investigation-of-medical-devices-and-clinical-performance-studies-of-in-vitro-diagnostic-ivd-medical-devices/
Purpose of the Draft Regulation
To establish the rules and requirements for conducting Clinical Investigation (CI) of Medical Devices and Clinical Performance Studies (CPS) of In-Vitro Diagnostic (IVD) Medical Devices in the Philippines.
To enhance participant safety, strengthen oversight of clinical studies, and ensure that clinical evidence generated in the Philippines meets internationally accepted quality standards.
Scope of Application
This draft regulation applies to sponsors and Contract Research Organizations (CROs) conducting clinical investigations of medical devices or clinical performance studies of IVD medical devices in the Philippines.
It is also relevant to companies planning studies involving Class B, C, and D medical devices and IVD medical devices.
Key Highlights
License to Operate Requirement
Sponsors and Contract Research Organizations (CROs) conducting clinical studies will be required to obtain a License to Operate (LTO) from the FDA.
Study Approval Requirements
Sponsors planning to conduct studies involving Class B, C, and D medical devices and IVD medical devices must first obtain the appropriate FDA approval before the study can begin.
The required approval may be:
- Clinical Investigation Approval (CIA), or
- Clinical Performance Study Approval (CPSA)
Approval from an accredited Ethics Committee will also be required.
Other Requirements
The draft regulation also sets out requirements for:
- Importation and labeling of investigational devices
- Reporting of serious adverse events, device deficiencies, and other safety-related incidents
- Submission of annual progress reports
- Amendments to study protocols
- Suspension or termination of studies
- FDA inspections to verify compliance with Good Clinical Practice (GCP), Good Study Practice (GSP), and applicable regulatory requirements
Consultation Period
Stakeholders are invited to submit comments to the Philippine FDA on or before 25 August 2026.
As this Administrative Order remains in draft form, its provisions may change before it is officially issued.
Implications to Clients
If the proposed regulation is finalized, companies planning to conduct clinical investigations or IVD clinical performance studies in the Philippines may need to comply with additional regulatory requirements before their studies can commence.
These include obtaining the necessary FDA licenses and approvals, implementing enhanced safety reporting, maintaining comprehensive study documentation, and preparing for possible FDA inspections.
Clients are encouraged to review the draft regulation early to determine how it may affect their ongoing or planned clinical studies.
Reviewing internal procedures, quality systems, and regulatory timelines in advance will help ensure a smoother transition once the regulation takes effect.
Businesses with an interest in conducting clinical studies in the Philippines should monitor further updates and consider participating in the consultation process by submitting comments to the Philippine FDA before 25 August 2026.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in the Philippines, please contact sales@andamanmed.com.