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 market access for high-quality medical devices.
Aligning with the Philippines FDA Requirements
Regulatory Authority
Pure Global can assist with Philippine's medical device registration, ensuring FDA approval to sell in the Filipino market.
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.
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.
Let's Talk,
Anywhere You Are.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.