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  • 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
  • Unlocking ASEAN with Pure Global: A Strategic Guide to HSA Singapore Medical Device Registration for US & EU MedTech Firms

    Unlocking ASEAN with Pure Global: A Strategic Guide to HSA Singapore Medical Device Registration for US & EU MedTech Firms
    2025/08/19

    This episode of ASEAN MedTech Insights dives deep into the strategic process of medical device registration in Singapore with the Health Sciences Authority (HSA). We explore why this island nation is a critical gateway to the Southeast Asian market and break down the essential steps for foreign manufacturers to gain market access.

    From the mandatory appointment of a local Singapore Registrant to leveraging existing international approvals for expedited review, we provide a clear roadmap for navigating one of Asia's most advanced regulatory systems. Discover how Singapore's adoption of the ASEAN Common Submission Dossier Template (CSDT) can become a cornerstone of your regional expansion strategy.


    Consider this common challenge. A European MedTech scale-up with a breakthrough Class C device and a CE mark wants to enter Asia. Their first choice is Singapore, but they have no physical presence, no local team, and are overwhelmed by the prospect of a long, complex regulatory process. They fear high costs and extended delays that could derail their entire regional launch. This episode details how they can overcome these hurdles by using their CE marking to qualify for an expedited pathway, cutting review times by nearly half and creating a streamlined process for future ASEAN submissions.


    Key questions from this episode:

    1. Why is Singapore often the essential first step for MedTech companies entering the ASEAN market?

    2. What is the single most critical requirement for any foreign manufacturer before submitting an application to the HSA?

    3. How can your existing FDA approval or CE mark dramatically accelerate your registration timeline in Singapore?

    4. Are all medical devices required to be registered? The answer for Class A devices might surprise you.

    5. What is the ASEAN CSDT, and how can it serve as your passport to multiple markets in Southeast Asia?

    6. What are the ongoing compliance duties you must fulfill even after your device is approved?

    7. How can you ensure your technical documentation is perfectly structured for both Singapore and future market expansions?

    8. What are the key differences between the full, abridged, and expedited evaluation routes?


    Pure Global offers end-to-end regulatory consulting to streamline your global market access. We combine local expertise with advanced AI and data tools, acting as your local representative in Singapore and over 30 other markets to ensure your MedTech innovation reaches patients faster. To learn more about how we can help you navigate the HSA registration process, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    3 分