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  • 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
    2025/08/28
    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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    3 分
  • MedTech ASEAN Insights by Pure Global: Mastering Device Classification under the AMDD for Seamless Market Entry in Thailand, Malaysia, and Indonesia

    MedTech ASEAN Insights by Pure Global: Mastering Device Classification under the AMDD for Seamless Market Entry in Thailand, Malaysia, and Indonesia
    2025/08/27
    This episode of ASEAN MedTech Insights delves into the cornerstone of market access in Southeast Asia: the ASEAN Medical Device Directive (AMDD) risk classification system. We break down the four-tier framework—from low-risk Class A to high-risk Class D—that governs how devices are regulated across all 10 member states. Understanding this system is non-negotiable for any manufacturer looking to tap into this dynamic and growing market. We go beyond the basics to explore the critical nuances that determine a device's classification. You'll learn why a product's 'intended use' can be more important than its physical design and how this impacts your entire regulatory strategy. We provide clear, real-world examples for each class, giving you the practical insights needed to position your product correctly from day one. Consider this: Your company has developed a groundbreaking Software as a Medical Device (SaMD) for remote patient monitoring. You see huge potential in the rapidly digitizing healthcare systems of Vietnam and the Philippines. However, you're struggling to classify it. Is it a low-risk Class B wellness app or a high-risk Class C diagnostic tool? A mistake here could lead to submission rejection, months of delays, and significant financial loss, putting your entire market entry plan at risk. 本期干货 1. Why is the AMDD considered a revolutionary step for MedTech access in Southeast Asia? 2. What is the single most important factor that determines your device's risk class? 3. How can two physically similar devices end up in completely different risk classes (B vs. C)? 4. What are some surprising examples of devices that fall into the highest-risk Class D category? 5. Why isn't a simple thermometer always considered a low-risk Class A device? 6. How does the principle of "intended use" create major regulatory hurdles in markets like Malaysia or Thailand? 7. What are the critical first steps to ensure your device classification is accurate *before* you prepare your technical dossier? 8. Which common devices, like blood bags or ventilators, fall into the Class C category and why? Navigating the diverse regulatory landscapes of ASEAN requires more than just knowledge—it demands local expertise. At Pure Global, we offer end-to-end regulatory consulting for MedTech and IVD companies, combining on-the-ground experts in over 30 markets with advanced AI tools to streamline your global market access. From initial regulatory strategy and technical dossier submissions to acting as your local representative, we make complex markets simple. Stop guessing and start scaling. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to accelerate your journey into the ASEAN market.
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    4 分
  • Unlocking Vietnam's MedTech Market: A Pure Global Deep Dive on Critical Labeling and Language Regulations for ASEAN Success.

    Unlocking Vietnam's MedTech Market: A Pure Global Deep Dive on Critical Labeling and Language Regulations for ASEAN Success.
    2025/08/26
    This episode of ASEAN MedTech Insights tackles one of the most significant hurdles for medical technology companies entering Vietnam: the country's strict and specific labeling and language regulations. We demystify the requirements under key decrees like Decree 98/2021/ND-CP, providing a clear path to compliance for foreign manufacturers. We break down the practical solutions that successful companies use, focusing on the accepted practice of supplementary labeling. Learn what mandatory information must be translated into Vietnamese and how to manage the critical Instructions for Use (IFU) to avoid your products being held at customs. This is a must-listen for any regulatory affairs professional, exporter, or business leader looking to succeed in the vibrant Vietnamese market. A specific case: Imagine this. Your state-of-the-art medical device, fully compliant in Europe and the US, is stuck at a Vietnamese port. The shipment is delayed, storage costs are mounting, and your local partner is frustrated. The reason is a simple missing Vietnamese-language sticker and a non-translated user manual. This common, costly scenario is entirely avoidable, and we explain how. What you'll learn in this episode: 1. What is the single mandatory language for all medical device labels in Vietnam? 2. Can I use a sticker on my original packaging to meet local requirements, and what are the rules? 3. What specific information must be included on a compliant Vietnamese label? 4. Are English Instructions for Use (IFU) ever acceptable, or must they always be translated? 5. What is the most common labeling mistake that causes customs delays for MedTech companies in Vietnam? 6. How does Decree 98/2021/ND-CP fundamentally change the labeling strategy for market entry? 7. Who is legally responsible for ensuring the label is correct before the product reaches the end-user? 8. Are there any exceptions for electronic or online user manuals? Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI and data tools to streamline global market access. We act as your local representative to ensure your market entry is smooth, compliant, and successful. To avoid common pitfalls and accelerate your growth in Vietnam and beyond, contact our experts at info@pureglobal.com or visit us at https://pureglobal.com/.
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    3 分
  • Pure Global's Guide to Indonesian Market Access: Choosing Your Local Authorized Representative in the Heart of ASEAN

    Pure Global's Guide to Indonesian Market Access: Choosing Your Local Authorized Representative in the Heart of ASEAN
    2025/08/25
    Navigating the Indonesian MedTech market presents a critical challenge for foreign manufacturers: the mandatory appointment of a Local Authorized Representative (LAR). This isn't merely an administrative step; it's a strategic decision that defines who controls your product's registration license and, ultimately, your access to one of Southeast Asia's largest markets. This episode of ASEAN MedTech Insights explores the two primary options for an LAR—appointing your distributor versus partnering with an independent third party. We uncover the hidden risks of tying your regulatory license to a commercial partner and explain why an independent representative provides the flexibility and control necessary for long-term success and scalability in the complex Indonesian archipelago. For example, consider a European diagnostics firm that allowed its sole distributor in Indonesia to hold its product licenses. When a disagreement arose over sales performance, the firm decided to switch partners, only to find their licenses were held hostage by the original distributor. This forced them into a costly, two-year re-registration process, effectively locking them out of the market and forfeiting significant revenue. Key Takeaways: * Why is appointing a Local Authorized Representative a mandatory first step for selling medical devices in Indonesia? * What are the hidden risks of allowing your distributor to be your legal license holder? * How does the ownership of the registration license (Izin Edar) impact your ability to change commercial partners? * What happens to your market access if your relationship with a distributor-representative ends poorly? * Why is an independent representative model considered a safer, more flexible strategy for market entry? * How can you build a multi-distributor network in Indonesia without re-registering your product for each one? * What is the strategic difference between regulatory control and commercial strategy in the ASEAN context? At Pure Global, we provide MedTech and IVD companies with end-to-end regulatory solutions, including acting as your independent Local Authorized Representative in Indonesia and over 30 markets worldwide. Our combination of local expertise and advanced AI tools streamlines your global market access. To maintain full control of your assets and build a flexible market strategy, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    3 分
  • Pure Global's ASEAN MedTech Insights: Leveraging Your CE Mark or FDA Approval for Expedited Medical Device Registration in Thailand

    Pure Global's ASEAN MedTech Insights: Leveraging Your CE Mark or FDA Approval for Expedited Medical Device Registration in Thailand
    2025/08/24
    In this episode of ASEAN MedTech Insights, we tackle a crucial question for global MedTech manufacturers: Can your existing CE mark or FDA approval fast-track your medical device registration in Thailand? We dive into the specifics of the Thai FDA's expedited pathways, explaining how you can leverage your prior approvals to gain a competitive edge in one of Southeast Asia's most dynamic markets. We explore the "Concise Evaluation Route," detailing which device classes are eligible and what the process actually entails. This is not a simple green light; it's a streamlined review that still demands meticulous preparation. A U.S. diagnostics company learned this the hard way. They assumed their FDA approval was a golden ticket into Thailand, only to face significant delays due to misunderstandings about local license holder requirements and the specific format needed for their technical documentation, costing them an estimated six months in lost revenue and market momentum. Key Takeaways: * What exactly is Thailand's "Concise Evaluation Route" and does my device qualify? * Is my FDA 510(k) or CE mark an automatic passport to the Thai market? * Beyond my approval certificate, what key documents does the Thai FDA still require? * Why is a local Thailand license holder mandatory even with an expedited application? * How can I format my existing technical files to meet the ASEAN CSDT standard? * What are the most common mistakes that lead to delays, even on an expedited pathway? * Are there language requirements for labeling and instructions that I need to know? * How does the expedited process in Thailand compare to other ASEAN countries like Malaysia or Vietnam? Struggling to turn your global approvals into rapid ASEAN market access? Pure Global offers end-to-end regulatory consulting, combining local expertise with advanced AI to streamline your entry into over 30 global markets. We act as your local representative and ensure your submission is right the first time. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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    2 分
  • Unlocking the Malaysian MedTech Market: A Pure Global Deep Dive into the MDA Registration Process for ASEAN Success

    Unlocking the Malaysian MedTech Market: A Pure Global Deep Dive into the MDA Registration Process for ASEAN Success
    2025/08/23
    This episode of ASEAN MedTech Insights provides a detailed guide to navigating the medical device registration process with Malaysia's Medical Device Authority (MDA). We break down the essential steps for foreign manufacturers, from the critical appointment of a local Authorized Representative (AR) to understanding the four-tiered device classification system and the electronic submission process through the MeDC@St portal. We explore the detailed requirements for creating a Common Submission Dossier Template (CSDT) and the mandatory conformity assessments by CABs for higher-risk devices. For instance, a promising US-based scaleup developing a novel diagnostic tool faced significant setbacks. They underestimated the nuances of the MeDC@St system, leading to repeated submission rejections. Their chosen local AR lacked the specific expertise to guide them, delaying their market entry by nearly a year and allowing a competitor to gain a foothold. This highlights how procedural knowledge is as crucial as product innovation. Key Takeaways for This Episode: 1. Why is appointing a Malaysian Authorized Representative the non-negotiable first step for market entry? 2. How does Malaysia's risk-based classification (Class A to D) impact your registration timeline and costs? 3. What are the most common errors foreign manufacturers make when submitting documents via the MeDC@St online portal? 4. When is a review by a Conformity Assessment Body (CAB) required, and how does it differ from other regulatory audits? 5. What specific post-market surveillance activities are mandatory to maintain your device registration in Malaysia? 6. Can your existing CE Mark or FDA approval accelerate the MDA registration process? 7. What are the key legal responsibilities your Authorized Representative holds on your behalf? Pure Global offers end-to-end regulatory consulting to streamline this entire process. We combine local expertise with advanced AI tools to ensure your MedTech and IVD products achieve efficient market access in Malaysia and beyond. To learn how we can act as your local representative and manage your regulatory journey, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 分
  • ASEAN MedTech Insights by Pure Global: A Deep Dive into Singapore's HSA Class C Device Registration - Common Pitfalls and Expedited Pathways

    ASEAN MedTech Insights by Pure Global: A Deep Dive into Singapore's HSA Class C Device Registration - Common Pitfalls and Expedited Pathways
    2025/08/22
    This episode of ASEAN MedTech Insights provides a detailed guide on registering a Class C medical device with Singapore's Health Sciences Authority (HSA). We explore the critical role of reference agency approvals from bodies like the US FDA and EU Notified Bodies, and how they can unlock expedited pathways, significantly reducing your time to market. We break down the specific requirements for the fastest route, the Expedited Class C Registration (ECR-1), and highlight the common, costly mistakes that can derail your submission. This is a must-listen for any MedTech company looking to successfully launch a moderate-to-high-risk device in the strategic Singaporean market. Imagine your innovative Class C device, already successful in Europe, facing unexpected nine-month delays in Singapore. The problem? A tiny discrepancy in the 'intended use' statement between your submissions, caused by a minor software update. This single oversight, a common pitfall we discuss, can cost you months of lost revenue and thousands in additional fees, pushing your entire ASEAN launch schedule off-track. Key Takeaways from this Episode: 1. What are the different evaluation routes for Class C devices in Singapore, and which one is the fastest? 2. How can prior approval from a reference agency cut your HSA review time by more than half? 3. What are the three specific criteria your device must meet to qualify for the Expedited Class C Registration (ECR-1) route? 4. Why is having an identical "intended use" statement the most critical part of your application? 5. What is the Common Submission Dossier Template (CSDT), and which documents are most frequently missed by applicants? 6. Why can't a foreign manufacturer directly register their device in Singapore? 7. What is the role of a Singapore Registrant, and how does this appointment impact your market access? 8. What are the most common reasons for HSA to reject an expedited registration application? Pure Global offers end-to-end regulatory consulting solutions for Medical Technology (MedTech) and In-Vitro Diagnostic (IVD) companies, combining local expertise with advanced AI and data tools to streamline global market access. Let us help you navigate the complexities of the ASEAN market. Contact Pure Global at info@pureglobal.com or visit us at https://pureglobal.com/.
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    3 分
  • Unlocking ASEAN MedTech Markets: A Pure Global Deep Dive into the Common Submission Dossier Template (CSDT) for Singapore, Malaysia, and Beyond.

    Unlocking ASEAN MedTech Markets: A Pure Global Deep Dive into the Common Submission Dossier Template (CSDT) for Singapore, Malaysia, and Beyond.
    2025/08/21
    In this episode of ASEAN MedTech Insights, we explore the ASEAN Common Submission Dossier Template (CSDT). Designed to unify medical device registration across Southeast Asia, the CSDT promises a simplified path to market. However, manufacturers often discover that a "common template" does not mean a common process. We uncover the practical challenges and country-specific hurdles that can delay or derail your expansion plans. We dive into the critical differences in how countries like Singapore, Malaysia, and Thailand interpret and implement the CSDT. We share a real-world case study of a MedTech company that prepared a flawless CSDT based on their CE marking file, only to face unexpected requirements for specific certificates in Malaysia and mandatory local language translations in Thailand. These seemingly small details led to significant budget overruns and a launch delay of several months, highlighting the costly gap between regulatory theory and market reality. Key Questions Answered in This Episode: - What exactly is the ASEAN CSDT and which countries have adopted it? - Is the CSDT a true "one-and-done" submission for the entire ASEAN region? - How do CSDT requirements in Singapore differ from those in Malaysia or Thailand? - What are the most common and costly mistakes companies make when preparing their dossier? - Why is your existing CE or FDA technical file not enough for a successful ASEAN submission? - What are the specific local language and labeling requirements you cannot afford to ignore? - Why is an in-country representative still essential despite a harmonized template? - How can you anticipate and budget for hidden costs like translation and additional certifications? Navigating the complexities of ASEAN's regulatory landscape requires more than just a template. Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI and data tools to streamline global market access. We act as your local representative in over 30 markets, ensuring your submissions meet the nuanced requirements of each country from the start. Stop letting unforeseen hurdles slow your growth. Contact Pure Global for a tailored market access strategy at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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    3 分