How to register a medical device in the Philippines

This video gives medical device manufacturers a clear guide to entering the Philippines’ high-growth healthcare market. With a population of 117 million and a rapidly expanding private healthcare sector, the Philippines is emerging as a key destination for global medtech innovation. The medical device market is projected to reach USD 1.04 billion by 2029 (9.16% CAGR), while the in-vitro diagnostics (IVD) sector is expected to climb to USD 350 million (5.63% CAGR). Imports already make up roughly 90% of devices sold, underscoring the country’s reliance on international manufacturers and creating strong opportunities for compliant, high-quality products.

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Topics covered in this video include:

• Market size, growth projections, and demand drivers for medical devices in the Philippines
• FDA (CDRRHR) classification rules under AMDD alignment
• Required documentation, labeling, and post-market obligations
• The importance of appointing a local representative for submissions and imports
• Practical shortcuts to reduce registration timelines and accelerate revenue
• How Pure Global supports FDA submissions, customs clearance, and compliance

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Regulatory oversight is managed by the Philippines Food and Drug Administration (FDA), specifically its Center for Device Regulation, Radiation Health, and Research (CDRRHR). Since adopting the ASEAN Medical Device Directive (AMDD), the Philippines has aligned its registration framework with regional best practices, improving transparency and predictability for foreign manufacturers. Devices are classified into Classes A–D by risk level, with higher classes requiring more extensive dossiers and review.

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Need help with Philippines registration?
Pure Global’s Manila-based experts combine local insight with AI-powered dossier tools to reduce administrative burdens and cut submission times. From device grouping and technical-file preparation to FDA approvals and ongoing vigilance, we manage the entire process end-to-end. With one streamlined pathway, we not only help you access the Philippines but also expand efficiently across ASEAN markets. Learn more about FDA Philippines Medical Device Registration.

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