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.
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).
Medical devices sold in Australia are regulated by the Therapeutic Goods Administration (TGA). Pure Global can assist with Australia medical device registration and act as your Australian Sponsor, ensuring TGA approval to sell in the Australian market.
In Australia, medical devices are classified according to the level of risk they present, similar to the EU's system. The TGA’s regulatory approach facilitates market entry for devices with CE certification, with special attention to high-risk devices through additional reviews.
Foreign manufacturers without an Australian entity must appoint an in-country representative, or an Australian Sponsor, who is responsible for:
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.
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.
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.
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.
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.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
Contact us
