『ASEAN MedTech Insights』のカバーアート

ASEAN MedTech Insights

ASEAN MedTech Insights

著者： Ran Chen
無料で聴く

このコンテンツについて

 Welcome to ASEAN MedTech Insights, the premier podcast dedicated to the thriving medical technology landscape of Southeast Asia. Each episode, we explore the cutting-edge innovations, investment trends, and regulatory developments in one of the world's fastest-growing markets. Join us for exclusive interviews with the founders, executives, and visionaries shaping the future of healthcare in the ASEAN region.Copyright 2025 Ran Chen 生物科学 科学 経済学
エピソード
  • Pure Global’s ASEAN Playbook: Baking AMDD-Driven English Labeling from Singapore into Your Pan-Asia Dossier Strategy

    Pure Global’s ASEAN Playbook: Baking AMDD-Driven English Labeling from Singapore into Your Pan-Asia Dossier Strategy
    2025/10/17
    In this episode of ASEAN MedTech Insights, we explore the critical importance of a harmonized yet localized labeling strategy for medical device companies targeting Southeast Asia. While the ASEAN Medical Device Directive (AMDD) promotes English as the standard for technical dossiers, relying solely on an English-first approach tailored for markets like Singapore can create significant barriers to entry in countries with specific national language requirements, such as Thailand and Indonesia. We discuss how to move beyond a reactive, market-by-market approach to a proactive, pan-ASEAN strategy. Learn why integrating multilingual labeling into your core regulatory dossier from day one is essential for avoiding costly delays, redesigns, and logistical challenges, ultimately accelerating your multi-market launch and turning regulatory compliance into a powerful competitive advantage. **What You'll Learn:** * Why can an English-only label strategy successful in Singapore become a major roadblock in other ASEAN markets? * What are the hidden costs and delays of overlooking local language requirements in countries like Thailand or Vietnam? * How does the ASEAN Medical Device Directive (AMDD) promote harmony while still allowing for critical national differences in labeling? * When is the right time to integrate multilingual labeling into your dossier—before or after your first ASEAN market entry? * How can a unified dossier strategy that anticipates local needs save you months, or even years, in your regional expansion timeline? * What specific steps should be included in your Quality Management System to manage a pan-ASEAN labeling process effectively? * Why is a local in-country representative essential for navigating these nuanced labeling norms? At Pure Global, we specialize in creating seamless regulatory strategies that blend global standards with local expertise. Our end-to-end solutions for MedTech and IVD companies leverage advanced AI and data tools to streamline market access across more than 30 countries, including the entire ASEAN region. Let us help you build a dossier that works everywhere. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
    続きを読む 一部表示
    2 分
  • Pure Global's ASEAN MedTech Insights: Mastering Vietnam's Regulatory Maze from Decree 98 to Decree 07 for Market Success.

    Pure Global's ASEAN MedTech Insights: Mastering Vietnam's Regulatory Maze from Decree 98 to Decree 07 for Market Success.
    2025/10/16
    In this episode of ASEAN MedTech Insights, we unravel the complex regulatory web governing medical devices in Vietnam. We provide a deep dive into the foundational Decree 98/2021, the detailed implementation guide of Circular 05/2022, and the critical deadline extensions provided by Decree 07/2023. This is a must-listen for any MedTech company currently in or planning to enter the fast-growing Vietnamese market. We break down what these changes mean for your product registration, documentation, and overall market access strategy, moving beyond legal jargon to provide actionable insights. Imagine being a manufacturer of a Class C diagnostic device, with your Vietnamese import license about to expire. The new regulations demand a complex technical dossier in a format your team has never prepared, and the deadline is fast approaching. A single mistake in the submission could lead to rejection, halting your sales and severing relationships with local distributors. This episode walks you through how to navigate this exact scenario. Key Takeaways: * What fundamental shift did Decree 98/2021 introduce to Vietnam's medical device approval process? * How does Circular 05/2022 specify the dossier requirements for high-risk devices? * Why was Decree 07/2023 considered a critical lifeline for foreign manufacturers? * What are the most common pitfalls when preparing a Common Submission Dossier Template (CSDT) for the Vietnamese authorities? * How can you effectively manage the transition from an old import license to a new marketing authorization number? * What are the current, final deadlines that your company absolutely cannot miss? * What role does a local license holder play under the new regulatory framework? Navigating ASEAN's regulatory environment requires specialized local knowledge and a global perspective. Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, leveraging local expertise and advanced AI tools to streamline your market access. From initial regulatory strategy and technical dossier submission to post-market surveillance, we act as your single partner for multiple markets. Contact us for a strategic consultation at info@pureglobal.com or visit https://pureglobal.com/.
    続きを読む 一部表示
    2 分
  • Philippines MedTech Expansion: A Deep Dive with Pure Global on FDA CDRRHR Compliance and Why Your Local Representative is Critical for Success in ASEAN

    Philippines MedTech Expansion: A Deep Dive with Pure Global on FDA CDRRHR Compliance and Why Your Local Representative is Critical for Success in ASEAN
    2025/10/15
    This episode of ASEAN MedTech Insights provides a deep dive into the specific regulatory requirements for medical device registration in the Philippines. We unpack the critical role of the FDA's Center for Device Regulation, Radiation Health, and Research (CDRRHR) and explain why foreign manufacturers cannot go it alone, detailing the mandatory appointment of a Local Authorized Representative. We explore the entire process, from securing the essential License to Operate (LTO) to navigating the AMDD risk classification system and preparing the ASEAN Common Submission Dossier Template (CSDT). A key focus is on the strategic importance of selecting the right local partner, as this decision directly impacts your market access, product control, and long-term success in this key ASEAN market. Consider a European startup with a breakthrough IVD product. They are poised for launch in the Philippines but discover their chosen distributor will be the legal owner of their product registration. This creates a critical dependency, meaning if they ever want to switch distributors, they would lose their market authorization and have to start the entire multi-year registration process from scratch, sacrificing revenue and market position. What you'll learn in this episode: 1. Why is a License to Operate (LTO) the absolute first step before any device submission in the Philippines? 2. How does the AMDD risk classification (A, B, C, D) determine your specific registration pathway? 3. What is the ASEAN Common Submission Dossier Template (CSDT) and what does it require? 4. What legal responsibilities does your Local Authorized Representative hold beyond just filing paperwork? 5. Why could choosing the wrong importer jeopardize your entire market presence and registration ownership? 6. What are the key differences between an independent representative and a distributor holding your license? 7. How are post-market surveillance and import clearances managed through your local partner? At Pure Global, we act as your independent, professional Local Authorized Representative in the Philippines and over 30 other markets. We secure your registration in your name, giving you full control over your assets. We manage the entire regulatory lifecycle, from initial strategy to post-market compliance, ensuring your path to market is secure and efficient. Don't tie your product's future to a single distributor. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to secure your market access with confidence.
    続きを読む 一部表示
    2 分
まだレビューはありません