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  • 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.
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    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/.
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    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.
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    2 分
  • 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
    2025/10/14
    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 分
  • 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
    2025/10/13
    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 分
  • Navigating Thailand's New AMDD Regulations: Why Pure Global's On-the-Ground Experts in Bangkok Are Essential for Your MedTech Success

    Navigating Thailand's New AMDD Regulations: Why Pure Global's On-the-Ground Experts in Bangkok Are Essential for Your MedTech Success
    2025/10/12
    Thailand is a top-tier MedTech market in ASEAN, but its regulatory landscape is shifting. With new rules aligned with the ASEAN Medical Device Directive (AMDD), foreign manufacturers face a critical hurdle: the mandatory appointment of a Local Authorized Representative (LAR). This isn't just a name on a form; it's a legal and strategic necessity. This episode of ASEAN MedTech Insights dives deep into the challenges and solutions for entering the Thai market. We explore why using a distributor as your LAR can be a costly mistake, how on-the-ground expertise in Bangkok is non-negotiable for smooth dealings with the Thai FDA, and how to maintain full control over your business assets while ensuring compliance. Imagine launching your innovative device in Thailand, only to find your market access held hostage by a distributor who owns your product license. Switching partners becomes a nightmare, costing you months of sales and thousands in re-registration fees because they control your legal gateway to the market. This episode explains how to avoid this exact scenario. Key Takeaways: * What are the specific legal risks of appointing your distributor as your Local Authorized Representative in Thailand? * How does Thailand's alignment with the AMDD practically change your technical dossier submission? * Why is having a physical presence in Bangkok more critical than ever for dealing with the Thai FDA? * What legal liabilities does your LAR hold, and how does that directly impact your business? * How can you regain control of your product registration if it's already held by a sales partner? * What are the three most common pitfalls foreign MedTech companies face when entering the Thai market? * Why is separating your regulatory and commercial strategies essential for long-term growth in ASEAN? Pure Global offers end-to-end regulatory consulting solutions, acting as your independent Local Authorized Representative in Thailand and over 30 other markets. We combine on-the-ground local expertise with advanced AI tools to streamline your global market access. Don't let regulatory hurdles block your expansion. Contact us at info@pureglobal.com or visit https://pureglobal.com to secure your market presence.
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    2 分
  • Pure Global's ASEAN MedTech Insights: Navigating Singapore's Class A Maze and the Hidden Dealer License Rule

    Pure Global's ASEAN MedTech Insights: Navigating Singapore's Class A Maze and the Hidden Dealer License Rule
    2025/10/11
    This episode of ASEAN MedTech Insights tackles a critical compliance hurdle in Singapore that catches many MedTech companies by surprise. We explore why the "registration-exempt" status for Class A medical devices is not a free pass to the market and detail the mandatory licensing requirements that are often overlooked. Many international manufacturers assume their low-risk Class A devices can be sold in Singapore without regulatory steps, leading to costly mistakes. We share a real-world case where a company's product launch was completely stalled at customs because their local distributor lacked the required license, a detail that was missed in their market entry strategy. This scenario highlights the hidden complexities and the importance of deep local regulatory knowledge. Key Takeaways: * What does "registration-exempt" for Class A devices in Singapore truly mean for a manufacturer? * Why is a dealer's license mandatory even when the product itself doesn't need to be registered? * What are the real-world consequences of ignoring this critical licensing requirement? * How does the Health Sciences Authority (HSA) maintain supply chain oversight for low-risk devices? * What is GDPMDS and why is it an essential certification for your Singaporean partners? * Are you certain your local distributor is fully compliant to import and sell your Class A device? * How can you avoid unexpected customs delays and regulatory penalties in Singapore? At Pure Global, we provide end-to-end regulatory consulting to help MedTech innovators navigate complex markets like Singapore and the broader ASEAN region. Our blend of local expertise and advanced data tools streamlines market access and ensures you are compliant every step of the way. Don't let regulatory surprises derail your expansion. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to secure your path to market.
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    2 分
  • Singapore MedTech Alert: Is Your Distributor Holding Your HSA Registration Hostage? Pure Global on Securing Your ASEAN Market Access.

    Singapore MedTech Alert: Is Your Distributor Holding Your HSA Registration Hostage? Pure Global on Securing Your ASEAN Market Access.
    2025/10/10
    In this episode of ASEAN MedTech Insights, we dive into one of the most critical and overlooked decisions for medical device companies entering the Singapore market: the appointment of your Health Sciences Authority (HSA) Registrant. Singapore is the region's premier hub, but a single misstep here can halt your regional expansion before it even begins. We explore why the common practice of appointing a commercial distributor as your legal Registrant is fraught with risk. This arrangement can lead to your product registration being held hostage, effectively giving a sales partner control over your market access and growth strategy across ASEAN. We break down how this happens and what it means for your business. **Key Takeaways:** * What is the single biggest mistake foreign MedTech companies make when entering Singapore? * Why should you never tie your legal device registration to a commercial distributor? * How does the HSA Registrant system in Singapore impact your ability to scale into markets like Malaysia and Vietnam? * What are the legal and financial risks of losing control of your product approval? * How can an independent, professional Registrant give you complete control over your commercial partners and sales strategy? * What is the process for fixing the problem if you've already appointed a distributor as your Registrant? * Why is a solid Singapore regulatory strategy the key to unlocking the entire ASEAN MedTech market? At Pure Global, we serve as your dedicated, independent Registrant in Singapore and beyond. We secure your market access while giving you the freedom to build the commercial strategy that's right for your business. Our end-to-end regulatory solutions combine local expertise with advanced AI to streamline your entry into over 30 global markets, including the entire ASEAN region. Don't let a simple mistake derail your growth. Take control of your assets. To learn more, contact our experts at info@pureglobal.com or visit https://pureglobal.com/.
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    2 分