FDA Philippines

Philippines - FDA Philippines

GuidanceLast updated · 2023Verified · 2026-10-17

AO 2018-0002 + FDA Circulars on SaMD and cybersecurity

Authority

Food and Drug Administration, Philippines, Center for Device Regulation, Radiation Health and Research

Enforced

2018

Legal framework

RA 9711 (FDA Act) + AO 2018-0002 + Data Privacy Act 2012

FDA package reuse

~80%

Editorial estimate · how →

Scope

All medical devices marketed in the Philippines; SaMD scope expanding via FDA Circulars.

Pre-market

Risk-class registration; ASEAN CSDT template; FDA / CE accepted.

Post-market

Adverse-event reporting; National Privacy Commission breach notifications.

SBOM

Recommended

Encouraged for SaMD; not yet mandated.

Vulnerability disclosure

DICT-CERT coordinated disclosure recommended.

Penalty

Registration cancellation; Data Privacy Act fines and criminal liability.

Unique requirements

01Philippine License to Operate (LTO)
02Philippine Authorised Representative
03Filipino / English IFU and labelling

Highlights

ASEAN CSDT template alignment
Data Privacy Act overlay
FDA / CE approvals accepted

Aligns with

ASEAN MDD IMDRF N60 ISO 13485

Timeline

2018
AO 2018-0002 published
2023
SaMD and cyber circulars expanded

Key documents

FDA Philippines - Draft Guidelines on Medical Device Software (MDSW)

https://www.fda.gov.ph/draft-for-comments-guidelines-on-the-regulation-of-medical-device-software-mdsw-by-the-food-and-drug-administration-fda/

FDA Philippines (homepage)

https://www.fda.gov.ph/

How to submit in Philippines

Playbook reviewed · 2026-07-16

Submission route

Philippine FDA Certificate of Product Registration (CPR)

Philippine FDA operates a CPR route with heavy reliance on GHTF founding-member approvals for higher-risk devices.

Authority portal

Step-by-step

Step 01
Appoint local representation
Most jurisdictions require a locally-established entity to hold the registration or act as authorised representative before submission.
Step 02
Reuse FDA or CE package as baseline
Adapt the cybersecurity subsection you already prepared for FDA or CE; regulators here typically accept the structure and ask for local labeling additions.
Step 03
Translate and localise
Local-language technical summary and labeling are usually mandatory; certified translation is safest.
Step 04
Submit + track queries
Respond to clarification rounds promptly; each unanswered question can add 30-90 days to the clock.

Evidence checklist

Item	Level	FDA equivalent	Notes
Cybersecurity documentation (baseline FDA or CE)	Required	SPDF
Local authorised representative agreement	Required	—
Local-language labeling and IFU	Required	—
SBOM	Recommended	—	Not mandatory but reduces clarification rounds.

Common FDA-PH rejections

No Licence to Operate (LTO) for local importer

Common

Fix · Ensure importer holds a valid LTO before filing.

Typical timeline

End-to-end window: 4-9 months

Phase 01

Local rep + dossier prep

2-4 months

Phase 02

Regulatory review

4-9 months

Phase 03

Approval + market entry

1-3 months

Related markets

United Kingdom

~80% FDA reuse

Taiwan

~80% FDA reuse

South Africa

~80% FDA reuse

Malaysia

~80% FDA reuse

Frequently asked about Philippines

Is SBOM required for medical devices in Philippines?

Recommended. Encouraged for SaMD; not yet mandated.

What does FDA Philippines require for pre-market cybersecurity?

Risk-class registration; ASEAN CSDT template; FDA / CE accepted.

What are the post-market cybersecurity obligations under FDA Philippines?

Adverse-event reporting; National Privacy Commission breach notifications.

What is the penalty for non-compliance with FDA Philippines cybersecurity rules?

Registration cancellation; Data Privacy Act fines and criminal liability.

How much of my FDA cybersecurity package is reusable in Philippines?

Roughly 80% - an editorial estimate based on overlapping evidence requirements (threat model, SBOM, security risk assessment, pen-test report).