ASEAN MedTech Insights Podcast Por Ran Chen arte de portada

ASEAN MedTech Insights

ASEAN MedTech Insights

De: Ran Chen
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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 Ciencia Ciencias Biológicas Economía
Episodios
  • Singapore AI MedTech: Pure Global on Cracking the HSA's New Regulatory Code

    Singapore AI MedTech: Pure Global on Cracking the HSA's New Regulatory Code
    Dec 17 2025
    Singapore is a leader in the ASEAN MedTech landscape, especially in adopting AI for healthcare. However, the Health Sciences Authority (HSA) has introduced sophisticated new guidelines for AI-powered medical devices that focus on the entire product lifecycle. This creates significant new challenges for manufacturers, who must now plan for continuous validation and post-market changes to their algorithms. In this episode, we explore a critical pain point through a case study of an AI diagnostics company. After successfully launching their product, they face the complex task of updating their learning algorithm. This requires a pre-approved Change Management Plan and rigorous documentation, a hidden hurdle that can drain resources and threaten market access if not handled by experts. This week's key questions: - Why is regulating a learning AI algorithm fundamentally different from a static medical device? - What is the "total product lifecycle approach" that Singapore's HSA now requires? - How does an AI's ability to learn become a major regulatory compliance risk? - What is a Change Management Plan and why is it now critical for your AI device submission in Singapore? - Are you truly prepared for the intense post-market surveillance demands for adaptive AI? - What are the hidden documentation burdens for AI devices that could derail your launch? - How can you prove your updated algorithm is still safe and effective? - What kind of clinical governance is needed to deploy an AI medical device in a hospital setting? Navigating the complexities of global MedTech regulations is a major challenge. At Pure Global, we offer end-to-end regulatory consulting for MedTech and IVD companies, using local expertise and advanced AI tools to streamline your market access. From developing your initial regulatory strategy and managing technical dossiers to acting as your local representative, we clear your path to market. Contact us to learn how we can help you launch and scale in over 30 markets. Email us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 m
  • Pure Global: Singapore & Malaysia's AI MedTech Regulation - The New Fast-Track Gambit.

    Pure Global: Singapore & Malaysia's AI MedTech Regulation - The New Fast-Track Gambit.
    Dec 16 2025
    This week, we dissect the groundbreaking joint "AI-Enabled Device Fast-Track Program" launched by Singapore and Malaysia. This new regulatory pathway promises to slash market approval times for AI medical software but introduces complex and continuous post-market compliance obligations that could catch many companies off guard. We explore the strategic implications for MedTech innovators, covering both the immense opportunity for rapid dual-market access and the hidden operational burdens of the new "living license" model. This episode is a must-listen for regulatory affairs professionals, startup founders, and investors focused on the future of digital health in Southeast Asia. **Key Questions Answered (本期干货):** * What are the specific eligibility criteria for the new Singapore-Malaysia AI MedTech fast-track program? * How can you leverage a single submission to unlock two key ASEAN markets at once? * What are the hidden post-market data reporting requirements that could risk your market license? * Is your current Quality Management System prepared for continuous, real-world performance monitoring? * How does this joint initiative signal a major regulatory shift for the entire ASEAN region? * What specific cybersecurity vulnerabilities must be addressed to meet the new mandatory standards? * Can you turn these stringent new compliance demands into a competitive advantage? Pure Global offers end-to-end regulatory consulting solutions for Medical Technology (MedTech) and In-Vitro Diagnostic (IVD) companies. We combine local expertise with advanced AI and data tools to streamline global market access and ensure you stay compliant in dynamic environments like ASEAN. To prepare your product for new opportunities like the AI Fast-Track Program, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 m
  • Pure Global: Kuala Lumpur's RegTech Game - Beyond the IMDEC Conference Buzz

    Pure Global: Kuala Lumpur's RegTech Game - Beyond the IMDEC Conference Buzz
    Dec 15 2025
    This week, we go beyond the conference brochures and flashy booths of the International Medical Device Exhibition & Conference (IMDEC) in Kuala Lumpur. We dissect the real conversations and policy shifts that are redefining MedTech market access in Malaysia and setting the tone for the entire ASEAN region. We uncover how AI is moving from a buzzword to a core component of the Medical Device Authority's (MDA) strategy. For MedTech manufacturers, this means the rules are changing. A European company recently learned this the hard way when a minor software update to their registered cardiovascular device nearly led to a major compliance breach under Malaysia's new 'Change Notification' guidelines. This episode explores how to avoid such pitfalls and stay ahead of the curve. Key Takeaways From This Episode: - What was the number one topic being discussed off-stage at the IMDEC conference? - How is Malaysia's MDA preparing to use AI to enforce its regulatory framework? - Why might your current Quality Management System soon be non-compliant in Malaysia? - What are the hidden risks in the new 'Change Notification' guidance for your registered devices? - Is e-labelling a suggestion or a fast-approaching mandate in key ASEAN markets? - How can a unified dossier strategy unlock multiple ASEAN markets simultaneously? - What did the Malaysian Minister of Health's speech *really* signal to foreign MedTech investors? Navigating these complex and shifting regulations is what we do best. Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI tools to streamline global market access. We act as your local representative and strategic partner, ensuring you not only enter the market but thrive in it. Contact Pure Global at info@pureglobal.com or visit us at https://pureglobal.com/.
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    2 m
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