IVD Medical Device Registration in Philippines
Our experienced regulatory affairs specialists provide comprehensive support, from initial classification and submission to post-market compliance, ensuring your IVD devices meet all regulatory requirements for the government of Philippines.
Why Register Your IVD Medical Device in Philippines?
Market Access
Market Access
The Philippines is one of the fastest-growing markets in Southeast Asia with a rapidly expanding healthcare sector. Registering your IVD device allows you to tap into this burgeoning market, providing access to a large and diverse patient population in need of advanced diagnostic solutions.
Credibility and Trust
Credibility and Trust
Obtaining FDA approval for your IVD devices enhances your credibility and trustworthiness in the eyes of healthcare professionals, patients, and business partners. It demonstrates your commitment to providing safe and effective diagnostic tools, thereby boosting your reputation and brand value.
Long-Term Growth
Long-Term Growth
With the increasing demand for quality healthcare services and diagnostic solutions, the Philippines offers significant opportunities for long-term growth. Registering your IVD devices ensures you are well-positioned to capitalize on future market developments and expand your presence in this dynamic region.
Our IVD Medical Device Registration Services
Regulatory Strategy
Customised regulatory strategy tailored to optimise the registration process for your IVD device. Our experts also offer guidance on the most efficient pathway to compliance with the Philippine FDA.
Dossier Preparation
Compiling and reviewing all necessary documentation that meets the FDA Philippines requirements.
Submission Management
Managing the entire submission process, including communication with the FDA Philippines and designated National Reference Laboratories.
Post-Market Compliance
Assist in adverse event reporting, change notifications and more.
Registration Process Overview
Step 1: Classification
IVD medical devices in the Philippines are defined and classified based on the current list by PFDA as per FMC 2014-005:
- Registrable Medical Device- included in FMC 2014-005
- Non-registrable Medical Device- not included in FMC 2014-005
Step 2: Submission
The application is sent via online. After receiving an acknowledgment receipt via email, payment should be made, and proof of payment shall be emailed to FDA in order to formally accept the application.
Step 3: Evaluation
Once payment is confirmed, the FDA Center for Device Regulation, Radiation Health, and Research (CDRRHR) will require documents such as:
- Device description including its raw materials
- Test procedures and expected performance specification
- Manufacturing procedure
- Pre-clinical studies
- Device labeling
- Instructions for use
- Risk analysis
- Existing regulatory approvals or market authorizations
- Manufacturer’s compliance with ISO 13485
↓
CDRRHR will release an endorsement letter to the applicable National Reference Laboratory (NRL).
↓
Products are tested by the NRL.
↓
The NRL requires further documentation and application process.
Step 4: Approval
If all documentation and testing results meet the requirements > the CDRRHR to issue the Certificate of Product Registration (CPR)
If requirements are not met > the CDRRHR will disapprove your application.
Do note that certain devices may require additional permits or registrations from other government agencies, local testing in accredited laboratories, or separate FDA permits for radiation or wireless connectivity features.
Step 1: Classification
IVD medical devices in the Philippines are defined and classified based on the current list by PFDA as per FMC 2014-005:
- Registrable Medical Device- included in FMC 2014-005
- Non-registrable Medical Device- not included in FMC 2014-005
Step 2: Submission
The application is sent via online. After receiving an acknowledgment receipt via email, payment should be made, and proof of payment shall be emailed to FDA in order to formally accept the application.
Step 3: Evaluation
Once payment is confirmed, the FDA Center for Device Regulation, Radiation Health, and Research (CDRRHR) will require documents such as:
- Device description including its raw materials
- Test procedures and expected performance specification
- Manufacturing procedure
- Pre-clinical studies
- Device labeling
- Instructions for use
- Risk analysis
- Existing regulatory approvals or market authorizations
- Manufacturer’s compliance with ISO 13485
↓
CDRRHR will release an endorsement letter to the applicable National Reference Laboratory (NRL).
↓
Products are tested by the NRL.
↓
The NRL requires further documentation and application process.
Step 4: Approval
If all documentation and testing results meet the requirements > the CDRRHR to issue the Certificate of Product Registration (CPR)
If requirements are not met > the CDRRHR will disapprove your application.
Do note that certain devices may require additional permits or registrations from other government agencies, local testing in accredited laboratories, or separate FDA permits for radiation or wireless connectivity features.
Typical Fees and Timeline
| Class | Fee (inclusive of 1% Legal Research Fund fee) | Timeline |
|---|---|---|
| CMDN (Class A) | PHP 7,575 | 1-2 months |
| CMDR (Class B, C, and D) | PHP 7,575 | 6-9 months |
| CPR (IVD) | PHP 1515* | 6-9 months** |
** Not including performance evaluation test by NRL (National reference Laboratory)
| Class | Fee (inclusive of 1% Legal Research Fund fee) | Timeline |
|---|---|---|
| Class A | PHP 5,050 | 1-2 months |
| Class B, C, and D | PHP 5,050 | 3-6 months |
| IVD | PHP 5,050* | 3-6 months** |
** Not including performance evaluation test by NRL (National reference Laboratory)
