Pure Global
🇵🇭

Philippines Medical Device Registration

Food and Drug Administration (FDA Philippines) approval timelines and requirements

2-4 months
Typical Timeline
4
Device Classes
No
MDSAP Accepted
Required
Philippines Local Agent

Philippines Medical Device Registration Overview

Philippines medical device registration through FDA Philippines typically takes 2-4 months for Class A devices. The official FDA Philippines target is 1-2 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.Philippines uses a 4-class (A, B, C, D) risk-based classification system. Foreign manufacturers must appoint a Philippines Local Agent to register devices in Philippines. Registration is valid for 5 years.

Registration Timeline by Device Class

Philippines uses a 4-class (A, B, C, D) risk-based classification system.

Class A

Notification

Low Risk
Official
1-2 months
Realistic
2-4 months

• Notification-based

Class B

Registration

Medium Risk
Official
3-6 months
Realistic
4-9 months
With Prior Approval
3-5 months

Accelerated with: FDA, EU CE Mark, ASEAN MRA

• ASEAN harmonization applies

GMP/QMS Required

Class C

Registration

High Risk
Official
4-8 months
Realistic
6-12 months
With Prior Approval
4-7 months

Accelerated with: FDA, EU CE Mark, ASEAN MRA

• Clinical data may be required

GMP/QMS Required

Class D

Full Registration

Highest Risk
Official
6-12 months
Realistic
9-18 months
With Prior Approval
6-10 months

Accelerated with: FDA PMA, EU CE Mark Class III

• Clinical evidence required

Clinical Trial RequiredGMP/QMS Required
Expedited Pathways

ASEAN Medical Device Directive

Harmonized registration within ASEAN

20-30% faster
Eligibility: Products registered in ASEAN MRA countries
Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Philippines registration.

FDA 510(k)
Documentation support
2-3 months
EU CE Mark
Documentation support
2-3 months
ASEAN MRA
Harmonized pathway
2-4 months
Key Requirements
  • Philippines Local Agent
  • English/Filipino labeling
  • ISO 13485 certification
  • Free Sale Certificate
  • CPR (Certificate of Product Registration)
Registration Validity:

5 years

Registration Process Flowchart

Philippines Medical Device Registration Process

Step-by-step FDA Philippines registration process. Total estimated timeline: 2-4 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by FDA Philippines. Appoint a Philippines Local Agent.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to FDA Philippines including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

FDA Philippines reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

1-2 months

In-depth technical assessment of device safety and performance. FDA Philippines may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, FDA Philippines issues Philippines market authorization certificate.

Summary: The Philippines medical device registration process through Food and Drug Administration (FDA Philippines) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Related Resources
FDA Philippines Regulation NewsGovernment Registration Fees
Compare With
🇺🇸 United StatesFDA🇪🇺 European UnionEU MDR🇨🇳 ChinaNMPA🇯🇵 JapanPMDA🇧🇷 BrazilANVISA🇨🇦 CanadaHealth Canada
View All 29 Countries →

Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.