Philippines

FDA Philippines Medical Device Registration

The Philippines, with a population of about 117 million, is the second most populous country in Southeast Asia and presents a significant opportunity for medical device manufacturers, given its growing healthcare sector and reliance on imported medical devices.

The country's integration into the ASEAN Medical Device Directive underscores its commitment to harmonizing regulatory standards and facilitating Philippines medical device registration for high-quality medical devices.

$1.04b

MD Market size

9.16%

MD Market CAGR

$0.35b

IVD Market size

5.63%

IVD Market CAGR

10.9%

GDP Expenditure CAGR

5.8%

Aging Population

The Philippines' medical devices market will reach $1.04B by 2029 (9.16% CAGR), and the IVD market$350.28M (5.63% CAGR). Growth is driven by rising healthcare spending, high medical device imports, and an aging population (5.8% 65+ in 2021).

Device Classification and Regulatory Pathways

Understanding Medical Device Registration in the Philippines

Regulatory Authority

Medical devices in the Philippines are regulated by the Food and Drug Administration (FDA) through the Center for Device Regulation, Radiation Health, and Research (CDRRHR). Pure Global supports manufacturers in navigating the Philippines FDA process, including classification, documentation, and licensing, and can act as your local representative to ensure compliant market access.

Classification

The Philippines uses a four-tier, risk-based classification system for medical devices: Class A (low risk), Class B (low-moderate), Class C (moderate-high), and Class D (high risk). Classification is based on intended use, invasiveness, and potential impact on patient health. This system aligns closely with frameworks used in the EU and ASEAN region. Accurate classification is essential to determine the correct regulatory pathway and submission requirements.

IVDs currently do not need to be registered in the Philippines, though new regulations regarding IVD registration are expected to be released soon.

Key Requirements

Foreign manufacturers must appoint a licensed distributor or authorized representative based in the Philippines. This representative is responsible for:

Ensuring accurate device classification and preparation of technical documentation.

Securing the appropriate certification, either a Certificate of Medical Device Notification (CMDN) for low-risk Class A devices or a Certificate of Medical Device Registration (CMDR) for Class B, C, and D devices.

Managing regulatory submissions, renewals, and post-market obligations with the FDA.

Regulatory submission requirements include:

A valid ISO 13485 certificate or equivalent quality system documentation for all devices.

Compliance with ASEAN CSDT documentation format.

Product registration validity of six years, with renewals required before expiration.

English labeling that meets local standards, including registration number.

Pure Global ensures your product meets all current FDA Circulars and regulatory expectations, reducing risk, avoiding delays, and accelerating access to the Philippine medical device market.

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How We Can Help

Tailored Support for Market Entry

Our services aim to simplify your regulatory journey in the Philippines:

Assistance with the classification and grouping of your products to identify the regulatory pathway.

Support in compiling the technical dossier required for FDA registration.

Acting as your local representative, handling the registration with CDRRHR, managing the importation process, and ensuring post-market compliance.

Frequently
Asked Questions

What is the regulatory authority for medical device registration in the Philippines?

The Food and Drug Administration (FDA) of the Philippines is the regulatory authority responsible for the registration and compliance of medical devices in the country. The ASEAN Philippines' integration into the ASEAN Medical Device Directive facilitates harmonized regulatory standards.

How are medical devices classified in the Philippines?

Medical devices in the Philippines are categorized from Class A (low risk) to Class D (high risk). This classification influences the complexity of the technical dossier required and the level of scrutiny applied during the Philippines medical device registration process.

What are the key requirements for foreign manufacturers to market medical devices in the Philippines?

Foreign manufacturers must appoint a licensed importer as their local representative. This representative is responsible for the FDA Philippines medical device registration and licensing of products. Additionally, manufacturers must compile and submit a comprehensive technical dossier in accordance with the specific requirements for the device's classification.

What role does the ASEAN Medical Device Directive (AMDD) play in the Philippines' medical device registration?

The ASEAN Medical Device Directive (AMDD) plays a significant role in the Philippines' medical device registration by harmonizing regulatory standards across ASEAN member states. This alignment with the ASEAN Medical Device Directive FDA Philippines facilitates market access for high-quality medical devices and ensures consistent regulatory requirements.

Single Process,
Multiple Markets

When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.