『Unlocking the Philippine MedTech Market: A Pure Global Deep Dive on Device Registration Costs, Timelines, and ASEAN Strategy』のカバーアート

Unlocking the Philippine MedTech Market: A Pure Global Deep Dive on Device Registration Costs, Timelines, and ASEAN Strategy

Unlocking the Philippine MedTech Market: A Pure Global Deep Dive on Device Registration Costs, Timelines, and ASEAN Strategy

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 This episode of ASEAN MedTech Insights provides a practical guide to the costs and timelines for medical device registration in the Philippines. We explore the critical role of device classification under the ASEAN Medical Device Directive and how it dictates your regulatory pathway, whether it's a simple notification for Class A devices or a full registration for Classes B, C, and D. We uncover the real-world timelines that often extend beyond official government estimates and break down the full cost structure, which includes not only FDA fees but also mandatory local representative fees and potential dossier preparation costs. This episode is essential for any MedTech company looking to enter one of Southeast Asia's most promising markets with a clear and realistic strategy. A common pain point we see is a company with a new Class C device budgeting only for the official FDA application fee, expecting a nine-month approval. They are then caught off guard by thousands of dollars in mandatory local representative fees and a timeline that stretches to over a year due to multiple rounds of technical questions from the regulator, derailing their entire regional launch plan. Key Takeaways: 1. Why is the risk classification of my device the most critical first step for registering in the Philippines? 2. What is the ASEAN Common Submission Dossier Template (CSDT) and why might my existing technical file be insufficient? 3. How do official timelines from the Philippine FDA differ from the real-world time it takes to get approval? 4. What are the "hidden" costs of registration, such as local representative fees, that go beyond government charges? 5. How can a single round of questions from the regulator add months, not weeks, to my product launch? 6. Is the "simple" notification pathway for Class A devices truly fast and straightforward? 7. Why is choosing the right local partner or importer one of the most important strategic decisions you will make? 8. What post-market responsibilities must I be prepared for even before I submit my application? Don't let regulatory hurdles block your access to the vibrant Philippine market. At Pure Global, we offer end-to-end regulatory consulting, combining deep local expertise with advanced AI tools to streamline your global market access. We act as your local representative, manage your technical dossier, and provide a clear strategy for success. Ready to expand into the ASEAN region with confidence? Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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