Philippines Medical Device Registration (FDA Philippines – Center for Device Regulation, Radiation Health and Research / CDRRHR)
1. Regulatory Authority & Framework
Philippines regulates medical devices under:
- Republic Act 9711 (FDA Act of 2009)
- AO 2018-0002 – Guidelines for medical device registration
- AO 2020-001A / 2021 updates – Risk classification & transition rules
- FDA Memorandum Circulars (ongoing updates for UDI, PMS, e-portal)
Regulatory body:
FDA Philippines – CDRRHR (Center for Device Regulation, Radiation Health, and Research).
Submission portal:
eServices Portal / eLTO / eRegistration platform.
2. Device Classification (Class A/B/C/D – ASEAN/GHTF-Aligned)
Philippines fully adopts the ASEAN Medical Device Directive (AMDD) classification:
| Class | Risk Level | Examples |
|---|---|---|
| Class A | Low | Bandages, non-sterile items |
| Class B | Low–Moderate | Suction pumps, infusion equipment |
| Class C | Moderate–High | Blood glucose meters, HF surgical devices |
| Class D | High | Ventilators, implantables, surgical robots |
Classification follows:
intended purpose, duration of use, invasiveness, active nature, software risk.
3. Registration Requirement Types
Philippines requires both establishment licensing & product registration:
3.1 Establishment Licensing (LTO – License to Operate)
All entities must first secure:
- LTO Importer – for foreign-made devices
- LTO Distributor / Wholesaler
- LTO Manufacturer (if local fabrication)
Foreign manufacturers must appoint a Local Authorized Representative (AR) who holds an LTO-Importer.
3.2 Product Registration Routes (AMDD-Aligned)
Route 1 – Notification (Class A devices)
- Simplified documentation
- Listing only
- Very fast (7–30 days)
- Validity: 5 years
Route 2 – Registration (Class B / C / D devices)
Standard Registration requires:
- ASEAN CSDT documents
- Safety & performance data
- ISO 13485
- FSC / proof of approval from country of origin
- Clinical evaluation (as applicable)
- Technical testing (electrical safety / EMC / biocompatibility depending on device)
Validity: 5 years
Review time: Typically 6–9 months (faster for complete dossiers)
Route 3 – Abridged / Reliance Pathway (Fast Track)
Eligibility:
Device approved in at least one Reference Regulatory Agency (RRA):
- US FDA
- EU CE
- Health Canada
- TGA Australia
- PMDA Japan
- HSA Singapore
Benefits:
- Reduced dossier requirements
- Faster evaluation (typically 2–4 months)
4. Dossier Requirements (CSDT – ASEAN Format)
Administrative Documents
- Application form
- Letter of Authorization (LOA) for Local AR
- Free Sale Certificate (FSC) / Certificate of Market Authorization
- ISO 13485 certificate
- Manufacturer license
- QMS documentation
Technical Documents (per CSDT)
- Device description & intended purpose
- Essential Principles checklist
- Design verification & validation
- Biocompatibility (ISO 10993)
- Electrical safety & EMC (IEC 60601)
- Software evidence (IEC 62304 + cybersecurity)
- Sterilization validation
- Risk management (ISO 14971)
- Clinical evaluation report (CER)
- Labeling & IFU (English allowed; Filipino optional)
- Performance testing (as applicable)
5. Fees & Timelines
5.1 Government Fees (Typical)
- Class A Notification: PHP 3,000–5,000
- Class B: PHP 7,000–12,000
- Class C: PHP 12,000–18,000
- Class D: PHP 18,000–20,000+
5.2 Review Timelines
- Class A: 1–4 weeks
- Class B: 4–6 months
- Class C: 6–9 months
- Class D: 9–12 months
- Abridged Route: 2–4 months
Timelines depend on dossier completeness & FDA queue.
6. Local Authorized Representative (AR)
The AR must hold an LTO-Importer and is responsible for:
- Registration submission
- Importation and customs clearance
- Product recall & vigilance reporting
- Advertising/marketing approval
- Post-market surveillance compliance
AR is tied to the registration number.
Multiple ARs allowed, but requires separate registrations.
7. Labeling Requirements
Philippine labeling must include:
- Device name & model
- Manufacturer information
- Authorized Representative information
- Country of origin
- Lot/serial number
- Manufacturing/expiry date
- Storage/handling conditions
- IFU in English (Filipino optional)
- UDI (implemented gradually as per new circulars)
Sticker labeling is allowed for imported devices.
8. Importation Requirements
After registration approval:
- Import under LTO-Importer license
- Customs clearance via Bureau of Customs
- Presentation of Certificate of Product Registration (CPR)
- Batch release documents if required
- Compliance with traceability & distribution reporting
9. Post-Market Surveillance
FDA Philippines imposes strict PMS requirements:
- Mandatory AE/incident reporting
- Field safety corrective action (FSCA)
- Product recalls
- Record keeping
- Advertising & promotion approvals
10. Notes for Your Device Portfolio (Consulting Perspective)
| Device Type | Expected Class | Philippines Requirements |
|---|---|---|
| Soft contact lenses | Class C | Strong biocompatibility + CER required |
| Surgical robots / AR/MR systems (SyngAR™) | Class D | Full dossier + cybersecurity, interoperability & electrical safety |
| High-frequency electrosurgical devices | Class C/D | EMC + 60601 + usability data important; CER expected |
| Blood glucose meters & strips | Class C | ISO 15197 test data required |
| Serum preparation device (single-use) | Class B/C | Sterilization & performance validation essential |
11. Advantages of the Philippines Market
- English documentation accepted
- ASEAN CSDT harmonization → easier multi-country submission
- Abridged pathway for CE/FDA devices
- Strong private hospital sector
- Fast Class A listing