Medical Device Registration in the Philippines

The Philippines’ healthcare market is rapidly growing, offering significant opportunities for medical device companies—but navigating its regulatory framework can be challenging and time-intensive. That’s where Andaman Medical steps in.

With our proven expertise in medical device registration in the Philippines, we simplify the process and provide clear guidance every step of the way. From interpreting local regulations to ensuring complete compliance, we help you overcome regulatory obstacles and accelerate your market entry. Whether you’re an emerging manufacturer or an established global brand, we manage the complexities so you can concentrate on delivering safe and effective medical technologies to patients and healthcare providers throughout the Philippines.

Medical device registration in Philippines

All medical devices, whether made locally or imported, must be registered with the Philippines FDA’s Center for Device Regulation, Radiation, Health, and Research (CDRRHR). Class A devices are registered through the online “e-notification portal system”. Class B, C, D, and IVD devices are registered via email.

Why Register Medical Devices in the Philippines?

Registering your IVD or medical device in the Philippines goes beyond simply fulfilling regulatory obligations—it opens the door to a rapidly expanding healthcare market with strong demand for innovative medical technologies.

At Andaman Medical, we offer full regulatory support to help you confidently navigate the Philippines’ registration process. From streamlining approvals to managing ongoing compliance, we stand by your side throughout the journey.

Here’s why the Philippines is a strategic market for your medical device registration:

Market Access

The Philippines is one of the fastest-growing markets in Southeast Asia2 with a rapidly expanding healthcare sector. Registering your medical 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

Obtaining FDA approval for your medical 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

With the increasing demand for quality healthcare services and diagnostic solutions, the Philippines offers significant opportunities for long-term growth. Registering your medical devices ensures you are well-positioned to capitalise on future market developments and expand your presence in this dynamic region.

Who Can Register a Medical Device in the Philippines?

For medical device registration in the Philippines, a company must first obtain a Licence to Operate (LTO) as a Medical Device Manufacturer or Distributor (MDDC). Distributor status includes importers, exporters, and wholesalers. The LTO can be applied for via the e-services system and is issued by the FDA.

Only local (Filipino) companies can apply for an LTO. Foreign manufacturers have three options to register their medical devices:

Options for Foreign Manufacturers

After choosing the route-to-market and ensuring the local company has a valid LTO, they can proceed to register the medical device with the FDA CDRRHR.

The Philippines, as a signatory to the ASEAN Medical Device Directive (AMDD), requires registration submissions to use the ASEAN Common Submission Dossier Template (CSDT) for Class B, C, and D devices. The CSDT is submitted online via email. Class A devices require e-notification via the e-notification portal system.

Once notified or registered, the FDA CDRRHR issues a Certificate of Medical Device Notification (CMDN), Certificate of Medical Device Registration (CMDR), or Certificate of Product Registration (CPR), which serves as the Marketing Authorization or Product Approval License.

The company that receives the CMDN/CMDR/CPR is the Product License Holder. Multiple registrations with different distributor licence holders are allowed if the agreement is non-exclusive. Change of ownership or transfer of the Product Approval License is allowed if the original licence holder relinquishes the right to distribute the product in the Philippines. This can be difficult and costly, hence the advantage of appointing an independent third party as the Product License Holder.

Definition and Classification of Medical Devices in the Philippines

A medical device is any instrument, apparatus, machine, implant, in vitro reagent, software, or related article intended by the manufacturer to be used for humans for purposes like:

Diagnosis, prevention, monitoring, treatment, or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury
Investigation, replacement, modification, or support of the anatomy or a physiological process
Support or sustaining life
Control of conception
Disinfection of medical devices
Providing information for medical or diagnostic purposes through in vitro examination of human specimens

These devices do not achieve their primary intended action by pharmacological, immunological, or metabolic means, but may be assisted by such means.

Classification of Medical Devices in the Philippines

Medical devices are classified based on risk according to the ASEAN Medical Device Directive (AMDD):

Class A: Low Risk
Class B: Low to Moderate Risk
Class C: Moderate to High Risk
Class D: High Risk

The risk class determines the documentary requirements for registration. Higher risk classes require more documentation.

In Vitro Diagnostic (IVD) Medical Devices

IVD devices are classified as registrable or non-registrable. Currently, only 8 IVD medical devices are considered registrable:

HIV (antibody and/or antigen), HBV (HBsAg and other markers), HCV (antibody and/or antigen), and syphilis kits
Single or combination drug screening test kits/reagents for alternative medicines
Blood typing sera for Anti-A, Anti-B, Anti-D, Anti-AB
Anti-human globulin reagents
Potentiators like enzyme, LISS, and albumin
Column agglutination test for crossmatching and blood typing
Pregnancy test kits/reagents
Leptospirosis test kits/reagents
Blood collection tubes

Medical Device Grouping in the Philippines

Currently, there is no “product grouping” available in the Philippines. Each specific medical device must be registered separately. However, under certain conditions, one application can be filed for multiple devices, although separate certificates of product registration will be issued:

Medical Device with Accessories: When accessories are intended to be sold separately.
Same Manufacturer, Different Plants: Devices from the same legal manufacturer, produced in different plants but distributed together in the Philippines.
Medical Device System: Systems where parts need to be used together
Same Use, Different Materials: Devices with the same intended use and manufacturing process but different raw materials.
Same Use, Different Design: Devices with the same intended use and manufacturing process but different designs.
Same Materials, Different Shapes/Uses: Devices with the same raw materials but different types or shapes, resulting in different specific intended uses.

The Registration Process

Recent changes to the medical device registration process in Thailand came into effect in February and March 2021. The process depends on the product’s classification and whether it is a new registration or already registered in Thailand. The validity of the current product licence also affects the process:

Submission Method

Class A Medical Devices: Submit via email.
Class B, C, D, and IVD Medical Devices: Low-Moderate Risk

Guidelines

Follow FDA Circular 2020-026 for application filing (amendments may occur as the COVID-19 situation progresses).

Process for Class A Devices

Fill out required fields and upload necessary documentation in the e-notification portal.
Undergo pre-assessment. If compliant, an order of payment is generated.
Process payment within 5 working days.

Process for Class B, C, D, and IVD Devices

FillReceive acknowledgment receipt via email.
Make payment and email proof of payment.
Process payment within 5 working days.

Submission Schedule

Class A: Submit via email.
Class B, C, D, and IVD:
- Thursdays for company names starting with numbers and letters A-M.
- Fridays for company names starting with letters N-Z.
- Maximum of 5 initial/renewal applications and 2 variation/change notifications per company per nominated day.

Required Documents

Device description
Pre-clinical studies
Device labelling
Instructions for use
Risk analysis
Existing regulatory approvals or market authorizations
Manufacturer’s compliance for ISO 13485

Additional Requirements

Some devices require separate FDA permits or registrations from other government agencies (e.g., devices containing/transmitting radiation or with wireless connectivity).
Specific products may need local testing in an accredited laboratory in the Philippines.

Evaluation Process

Once payment is made, FDA CDRRHR will formally accept the application for evaluation.
If documentation meets requirements, FDA CDRRHR issues CMDN/CMDR/CPR (marketing authorization).
If documentation is insufficient, FDA CDRRHR requests additional documentation.
Upon resubmission, FDA CDRRHR re-evaluates and may issue marketing authorization or reject the submission.

Registration Process Overview

Submission Method

Class A Medical Devices: Submit via email.
Class B, C, D, and IVD Medical Devices: Low-Moderate Risk

Guidelines

Follow FDA Circular 2020-026 for application filing (amendments may occur as the COVID-19 situation progresses).

Process for Class A Devices

Fill out required fields and upload necessary documentation in the e-notification portal.
Undergo pre-assessment. If compliant, an order of payment is generated.
Process payment within 5 working days.

Process for Class B, C, D, and IVD Devices

FillReceive acknowledgment receipt via email.
Make payment and email proof of payment.
Process payment within 5 working days.

Submission Schedule

Class A: Submit via email.
Class B, C, D, and IVD:
- Thursdays for company names starting with numbers and letters A-M.
- Fridays for company names starting with letters N-Z.
- Maximum of 5 initial/renewal applications and 2 variation/change notifications per company per nominated day.

Required Documents

Device description
Pre-clinical studies
Device labelling
Instructions for use
Risk analysis
Existing regulatory approvals or market authorizations
Manufacturer’s compliance for ISO 13485

Additional Requirements

Some devices require separate FDA permits or registrations from other government agencies (e.g., devices containing/transmitting radiation or with wireless connectivity).
Specific products may need local testing in an accredited laboratory in the Philippines.

Evaluation Process

Once payment is made, FDA CDRRHR will formally accept the application for evaluation.
If documentation meets requirements, FDA CDRRHR issues CMDN/CMDR/CPR (marketing authorization).
If documentation is insufficient, FDA CDRRHR requests additional documentation.
Upon resubmission, FDA CDRRHR re-evaluates and may issue marketing authorization or reject the submission.

Submission Method

Class A Medical Devices: Submit via email.
Class B, C, D, and IVD Medical Devices: Low-Moderate Risk

Guidelines

Follow FDA Circular 2020-026 for application filing (amendments may occur as the COVID-19 situation progresses).

Process for Class A Devices

Fill out required fields and upload necessary documentation in the e-notification portal.
Undergo pre-assessment. If compliant, an order of payment is generated.
Process payment within 5 working days.

Process for Class B, C, D, and IVD Devices

FillReceive acknowledgment receipt via email.
Make payment and email proof of payment.
Process payment within 5 working days.

Submission Schedule

Class A: Submit via email.
Class B, C, D, and IVD:
- Thursdays for company names starting with numbers and letters A-M.
- Fridays for company names starting with letters N-Z.
- Maximum of 5 initial/renewal applications and 2 variation/change notifications per company per nominated day.

Required Documents

Device description
Pre-clinical studies
Device labelling
Instructions for use
Risk analysis
Existing regulatory approvals or market authorizations
Manufacturer’s compliance for ISO 13485

Additional Requirements

Some devices require separate FDA permits or registrations from other government agencies (e.g., devices containing/transmitting radiation or with wireless connectivity).
Specific products may need local testing in an accredited laboratory in the Philippines.

Evaluation Process

Once payment is made, FDA CDRRHR will formally accept the application for evaluation.
If documentation meets requirements, FDA CDRRHR issues CMDN/CMDR/CPR (marketing authorization).
If documentation is insufficient, FDA CDRRHR requests additional documentation.
Upon resubmission, FDA CDRRHR re-evaluates and may issue marketing authorization or reject the submission.

Typical Fees and Timelines

Fees

Each new medical device registration, renewal, or variation/change notification requires a fee.

Timelines

New Registrations: Typically take 6-9 months. If additional documentation is needed, the FDA CDRRHR allows 30 days for submission. Evaluation of compliance takes about 3 months, extending the total timeline to 9-12 months.
Renewals: General timeline is 3-6 months.

Fees and Timelines for New Registrations

Class	Fee (inclusive of 1% Legal Research Fund fee)	Timeline
CMDN (Class A)	PHP 81,810	1-2 months
CMDR (Class B)	PHP 109,080	6-9 months
CMDR (Class C)	PHP 112,110	6-9 months
CMDR (Class D)	PHP 118,170	6-9 months
CPR (IVD)***	PHP 113,928*	6-9 months**
CPR (IVD)****	PHP 107,262*	6-9 months**

* Does not include the cost for the performance evaluation test. Cost of testing depends on the corresponding National Reference Laboratory (NRL)
** Not including performance evaluation test by NRL (National reference Laboratory)
*** Pregnancy Test Kits – Existing Regulations
**** IVD – Existing Regulations

Fees and Timelines for Renewals

Class	Fee (inclusive of 1% LRF fee)	Timeline
Class A, B, C, D	PHP 92,718	1-2 months
IVD***	PHP 99,990*	3-6 months**
IVD****	PHP 93,324*	3-6 months**

* Does not include the cost for the performance evaluation test. Cost of testing depends on the corresponding National Reference Laboratory (NRL)
** Not including performance evaluation test by NRL (National reference Laboratory)
*** Pregnancy Test Kits – Existing Regulations
**** IVD – Existing Regulations

Fees and Timelines for Variation/Change Notification

Class	Fee per product/change (inclusive of 1% LRF fee)	Timeline
Class A	PHP 510	1-2 months
Class B, C, D	PHP 510	1-2 months
IVD	PHP 510	1-2 months

Navigating medical device registration in Philippines can be complex, but Andaman Medical is here to simplify the process and ensure you stay fully compliant. Connect with our experts today and take the first step toward smooth registration!

Medical Device Registration in the Philippines

Medical device registration in Philippines