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Navigating the Regulatory Pathways for Medical Devices

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 market access for high-quality medical devices.

Device Classification and Regulatory Pathways

Aligning with the Philippines FDA Requirements

Regulatory Authority

The Center for Device Regulation, Radiation Health, and Research (CDRRHR) of the Philippines Food and Drug Administration (FDA) oversees the medical device registration process. Following the ASEAN Medical Device Directive, the Philippines classifies medical devices into four classes (A, B, C, and D) based on the level of risk, guiding the regulatory requirements and submission process.

Classification

Medical devices are categorized from Class A (low risk) to Class D (high risk), influencing the complexity of the technical dossier and the scrutiny applied during the registration process.

Key Requirements

Foreign manufacturers looking to enter the Philippine market must:

  • Appoint a licensed importer as the local representative responsible for the registration and licensing of products with the Philippines FDA.
  • Compile and submit a comprehensive technical dossier as part of the registration process, adhering to the specific requirements for the device's classification.
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.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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