Épisodes

  • Singapore's Class III MedTech: The FDA "Shortcut" That Isn't | Pure Global Insights

    Singapore's Class III MedTech: The FDA "Shortcut" That Isn't | Pure Global Insights
    Oct 21 2025
    Getting a high-risk, Class III medical device to market is a major hurdle. While securing FDA approval is a huge milestone, many companies assume this translates to easy access in key ASEAN markets like Singapore. In this episode, we explore the reality of this process. We break down Singapore's Health Sciences Authority (HSA) abridged evaluation route for devices with prior FDA approval. Discover how this pathway can accelerate your market entry, but also learn about the critical nuances and local requirements that are often overlooked. Case In Point: We examine the case of a US company with an FDA-approved cardiovascular stent. They expected a quick registration in Singapore but hit unexpected roadblocks. Learn how they navigated the requirement for a local registrant and addressed specific HSA queries, ultimately cutting their registration time in half compared to a full evaluation. In This Episode, You'll Learn: - Why is Singapore a top-tier entry point for MedTech in ASEAN? - How does the HSA view prior approval from the US FDA? - What exactly is an "abridged evaluation," and how does it differ from a full review for a Class III device? - Is FDA approval a guarantee for faster registration in Singapore? - What are the common pitfalls companies face even with a strong US dossier? - Why is a local Singapore Registrant essential for your application? - What kind of questions can you expect from the HSA during the review? Navigating global regulations requires local expertise and a strategic approach. At Pure Global, we offer end-to-end regulatory consulting solutions for MedTech and IVD companies, using local experts and advanced AI to streamline your global market access. Don't let regulatory hurdles slow your growth. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can help.
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    2 min
  • Pure Global's ASEAN MedTech Insights: Unlocking Malaysia & a Faster ASEAN Market Entry via Singapore's HSA Approval

    Pure Global's ASEAN MedTech Insights: Unlocking Malaysia & a Faster ASEAN Market Entry via Singapore's HSA Approval
    Oct 19 2025
    This episode of ASEAN MedTech Insights delves into a powerful strategy for navigating the complex regulatory landscape of Southeast Asia. We uncover how MedTech companies can strategically leverage Singapore's Health Sciences Authority (HSA) approval to significantly accelerate market entry into other key ASEAN nations. Discover how a single, robust regulatory approval can act as a key to unlock multiple markets, saving you invaluable time and resources. We will explore a common scenario: a company with an innovative device ready for Asia faces the daunting prospect of separate, lengthy registration processes in Malaysia, the Philippines, and Thailand. This fragmented approach often leads to years of delays and spiraling costs, draining momentum and capital before the first product is even sold. This episode provides a direct solution to this critical pain point. Key Questions Answered in This Episode: * Why is Singapore's HSA considered a "gold standard" reference agency in the ASEAN region? * Which specific ASEAN countries offer expedited registration for devices with HSA approval? * How can leveraging HSA approval cut your market entry timeline in Malaysia by months? * What is the Common Submission Dossier Template (CSDT) and how can you repurpose it for multiple ASEAN markets? * What are the documentation pitfalls to avoid when using this abridged pathway strategy? * How does this strategy apply differently to Class B versus higher-risk Class C and D devices? * What are the specific advantages for companies that already have a CE mark or FDA clearance? At Pure Global, we specialize in creating and executing these efficient, multi-market regulatory strategies. Our local experts and advanced AI tools streamline the entire process, from initial HSA submission to post-market surveillance across the ASEAN region. To transform your market access plan, contact our experts at info@pureglobal.com or visit us at https://pureglobal.com/.
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    2 min
  • ASEAN MedTech Insights: Cracking Singapore's HSA Code - A Deep Dive into Device Classification & Grouping with Pure Global's Local Experts

    ASEAN MedTech Insights: Cracking Singapore's HSA Code - A Deep Dive into Device Classification & Grouping with Pure Global's Local Experts
    Oct 18 2025
    In this episode of ASEAN MedTech Insights, we demystify one of the most critical hurdles for entering Singapore's lucrative medical device market: device classification and grouping. A misstep here can lead to costly delays and outright rejections from the Health Sciences Authority (HSA). We explore how ASEAN innovators can navigate this complex landscape. We break down the four-tier risk classification system and reveal how a strategic approach to device grouping can save you hundreds of thousands of dollars and slash your time-to-market, turning a regulatory burden into a competitive edge. Consider this scenario: A Malaysian IVD company wants to launch a family of five diabetes test kits. Are they facing five separate, costly registration processes? We explore how they navigated this exact challenge, avoiding months of delays and a massively inflated budget by leveraging expert grouping advisory. Key Takeaways from this episode: * Why is Singapore's four-tier risk classification system more nuanced than it appears? * What common mistake in device classification can lead to a complete rejection of your HSA submission? * How can you legally bundle multiple medical devices into a single, cost-effective application? * What are the three essential criteria for successful device grouping in Singapore? * How does a product's intended use dramatically impact its classification and potential for grouping? * When should you seek local expert advisory before even starting your technical dossier? * What are the unwritten rules of the HSA that you won't find in the official guidelines? Tired of regulatory guesswork? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, leveraging local expertise and advanced AI to streamline market access in Singapore and over 30 markets worldwide. Whether it's developing a bulletproof registration strategy or acting as your official local representative, we clear the path for your innovation. Contact our experts today at info@pureglobal.com or learn more at https://pureglobal.com/.
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    2 min
  • 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
    Oct 17 2025
    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.
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    2 min
  • 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.
    Oct 16 2025
    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/.
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    2 min
  • 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
    Oct 15 2025
    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.
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    2 min
  • Navigating Indonesia's MedTech Maze: Why Your Local Representative is Key to Market Access with Pure Global

    Navigating Indonesia's MedTech Maze: Why Your Local Representative is Key to Market Access with Pure Global
    Oct 14 2025
    This episode of ASEAN MedTech Insights tackles a critical hurdle for global MedTech companies eyeing the Indonesian market: the mandatory appointment of a Local Authorized Representative (LAR). We explore why this is more than a procedural step and how the right partner can make or break your market access strategy. Imagine spending months preparing your technical dossier, only to have your product registration in Indonesia tied to an underperforming distributor. You're losing sales and want to switch partners, but you can't. The distributor, acting as your LAR, owns the product license. You are now faced with either losing market presence for over a year to re-register, or staying in a partnership that hurts your brand. This episode explains how to avoid this common and costly pitfall. Key questions from this episode: 1. What specific license must a company hold to be a Local Authorized Representative in Indonesia? 2. Why is appointing your distributor as your authorized representative a significant business risk? 3. What happens to your product registration if you terminate your relationship with a distributor who also acts as your LAR? 4. How does separating your regulatory representative from your commercial distributor give you more control? 5. What are the essential documents, like ISO 13485, required for the registration process? 6. How can an independent LAR streamline your entry and long-term strategy in the Indonesian market? 7. What are the legal responsibilities of an LAR for your medical device in Indonesia? Pure Global offers end-to-end regulatory consulting solutions, acting as your independent local representative in Indonesia and over 30 other markets. We use local expertise and advanced AI tools to streamline global market access, ensuring you maintain full control of your assets. Let us help you navigate the complexities of global expansion. Contact Pure Global at info@pureglobal.com or visit us at https://pureglobal.com/.
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    2 min
  • Pure Global's Guide to ASEAN Market Entry: Mastering Malaysia’s Medical Device Act 2012 for Full Registration

    Pure Global's Guide to ASEAN Market Entry: Mastering Malaysia’s Medical Device Act 2012 for Full Registration
    Oct 13 2025
    This episode of ASEAN MedTech Insights delves into the critical requirements of Malaysia's Medical Device Act 2012 (Act 737). We unpack the mandatory full registration process that every medical device must undergo, highlighting the specific and often underestimated hurdles that foreign manufacturers face when entering this key ASEAN market. We explore the entire journey, from the initial shock of regulatory requirements to the detailed steps for a successful submission. Learn why existing international approvals are not a direct passport to the Malaysian market and how local nuances in the registration process can lead to costly delays if overlooked. **Case In Point:** Imagine your advanced, CE-marked product launch in Malaysia is stalled for over nine months. Your submission was rejected before it even reached the authorities. The reason? A fundamental misunderstanding of two local requirements under Act 737: the non-negotiable need for an in-country Authorized Representative and the mandatory use of the CSDT dossier format. This common oversight is currently costing companies significant time, resources, and market opportunity. **Key Takeaways From This Episode:** * Why is Malaysia's Act 737 a critical gatekeeper for all MedTech devices? * Is your CE Mark or FDA approval enough for a smooth registration process in Malaysia? * What is the mandatory legal role of a Malaysia Authorized Representative and why can't foreign firms submit directly? * How does the MeDC@St online system actually work for foreign companies? * What is a Conformity Assessment Body (CAB) and how does its review impact your submission timeline? * What are the most common documentation errors that lead to immediate rejection? * How can you accurately budget for both time and costs when planning your Malaysian market entry? At Pure Global, we eliminate these uncertainties. We provide end-to-end regulatory solutions, acting as your local Authorized Representative in Malaysia and over 30 other markets. Our team of local experts, powered by advanced AI tools, reformats your technical dossiers, manages CAB reviews, and handles submissions through the MeDC@St portal to ensure compliance and accelerate your market access. Don't let regulatory hurdles slow your growth in ASEAN. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to streamline your global expansion.
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    2 min