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Unlock ASEAN MedTech Markets with Pure Global: A Masterclass on Device Risk Classification in Singapore, Malaysia, and Vietnam under ACCSQ/MDPWG/GL-2
This episode of ASEAN MedTech Insights demystifies the essential first step for market entry: medical device risk classification. We provide a clear breakdown of the ASEAN Medical Device Directive's four-tier system (Class A, B, C, and D), explaining how to navigate the harmonized rules based on the ACCSQ/MDPWG/GL-2 guidelines. This is your essential guide to ensuring your product's regulatory pathway is built on a solid foundation.
Learn the core principles that determine a device's risk level, including duration of use, invasiveness, and whether it's an active or non-active device. We move beyond theory with concrete examples, illustrating how products from a simple scalpel to complex AI-powered diagnostic software are classified. This practical insight will help you avoid common pitfalls that can lead to costly delays and rejections in key ASEAN markets.
**Key Takeaways from This Episode:**
* What are the four risk classes under the AMDD and how do they define your registration strategy?
* How does duration of contact—transient, short-term, or long-term—impact your device's classification?
* Why is a non-invasive device treated differently than a surgically invasive one?
* What are the special rules for active devices that administer energy or medicine?
* How is Software as a Medical Device (SaMD) risk classified within the ASEAN framework?
* What is the biggest mistake companies make when interpreting the invasiveness rules?
* Why might a device have a different classification in Singapore compared to the EU or US?
At Pure Global, we specialize in helping MedTech and IVD companies achieve seamless market access across ASEAN and over 30 markets worldwide. Our team combines local regulatory expertise with advanced AI tools to develop efficient pathways for your product registration, from initial strategy to post-market surveillance. Stop navigating complex regulations alone. Contact us for an end-to-end solution at [email protected] or visit https://pureglobal.com/.
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By Ran ChenThis episode of ASEAN MedTech Insights demystifies the essential first step for market entry: medical device risk classification. We provide a clear breakdown of the ASEAN Medical Device Directive's four-tier system (Class A, B, C, and D), explaining how to navigate the harmonized rules based on the ACCSQ/MDPWG/GL-2 guidelines. This is your essential guide to ensuring your product's regulatory pathway is built on a solid foundation.
Learn the core principles that determine a device's risk level, including duration of use, invasiveness, and whether it's an active or non-active device. We move beyond theory with concrete examples, illustrating how products from a simple scalpel to complex AI-powered diagnostic software are classified. This practical insight will help you avoid common pitfalls that can lead to costly delays and rejections in key ASEAN markets.
**Key Takeaways from This Episode:**
* What are the four risk classes under the AMDD and how do they define your registration strategy?
* How does duration of contact—transient, short-term, or long-term—impact your device's classification?
* Why is a non-invasive device treated differently than a surgically invasive one?
* What are the special rules for active devices that administer energy or medicine?
* How is Software as a Medical Device (SaMD) risk classified within the ASEAN framework?
* What is the biggest mistake companies make when interpreting the invasiveness rules?
* Why might a device have a different classification in Singapore compared to the EU or US?
At Pure Global, we specialize in helping MedTech and IVD companies achieve seamless market access across ASEAN and over 30 markets worldwide. Our team combines local regulatory expertise with advanced AI tools to develop efficient pathways for your product registration, from initial strategy to post-market surveillance. Stop navigating complex regulations alone. Contact us for an end-to-end solution at [email protected] or visit https://pureglobal.com/.