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ASEAN MedTech Maze: Pure Global's Guide to Device Registration in Singapore, Malaysia and Beyond
This episode of ASEAN MedTech Insights unpacks the complex web of medical device registration across Southeast Asia. We explore the promise of the ASEAN Common Submission Dossier Template (CSDT) and contrast it with the on-the-ground realities in key markets.
We dive into the distinct regulatory pathways of Singapore, known for its efficiency and reliance on reference country approvals, and Malaysia, with its mandatory MeDC@St online portal and Conformity Assessment Body (CAB) verification system. We highlight how these subtle differences can significantly impact a company's timeline and budget.
Consider the case of a US-based scaleup with an innovative cardiac monitoring device. They secured FDA clearance and targeted both Singapore and Malaysia for their Asian launch. They breezed through Singapore's abridged evaluation route in four months. However, they were unprepared for Malaysia's CAB requirement. Finding and contracting a CAB, submitting the dossier for review, and waiting for verification added an unexpected five months and thousands of dollars to their project, completely desynchronizing their regional launch and marketing efforts.
Key Takeaways:
1. What is the ASEAN CSDT, and why doesn't it guarantee a "register once, sell anywhere" reality?
2. How can a CE Mark or FDA approval accelerate your registration in Singapore but not necessarily in other ASEAN nations?
3. What is the specific role of a Conformity Assessment Body (CAB) in Malaysia's registration process?
4. Why is having a single local representative for the entire ASEAN region often not a viable strategy?
5. How will the upcoming Singapore-Malaysia regulatory reliance pilot program impact market entry strategies from 2025 onwards?
6. What are the key differences in post-market surveillance requirements between Vietnam and Thailand?
7. How do you choose the right first market in ASEAN for your specific device class?
At Pure Global, we offer end-to-end regulatory consulting solutions for MedTech and IVD companies. We combine local expertise with advanced AI and data tools to streamline your global market access, turning regulatory hurdles into strategic advantages. To learn how we can accelerate your entry into the ASEAN market, contact us at [email protected] or visit https://pureglobal.com/.
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By Ran ChenThis episode of ASEAN MedTech Insights unpacks the complex web of medical device registration across Southeast Asia. We explore the promise of the ASEAN Common Submission Dossier Template (CSDT) and contrast it with the on-the-ground realities in key markets.
We dive into the distinct regulatory pathways of Singapore, known for its efficiency and reliance on reference country approvals, and Malaysia, with its mandatory MeDC@St online portal and Conformity Assessment Body (CAB) verification system. We highlight how these subtle differences can significantly impact a company's timeline and budget.
Consider the case of a US-based scaleup with an innovative cardiac monitoring device. They secured FDA clearance and targeted both Singapore and Malaysia for their Asian launch. They breezed through Singapore's abridged evaluation route in four months. However, they were unprepared for Malaysia's CAB requirement. Finding and contracting a CAB, submitting the dossier for review, and waiting for verification added an unexpected five months and thousands of dollars to their project, completely desynchronizing their regional launch and marketing efforts.
Key Takeaways:
1. What is the ASEAN CSDT, and why doesn't it guarantee a "register once, sell anywhere" reality?
2. How can a CE Mark or FDA approval accelerate your registration in Singapore but not necessarily in other ASEAN nations?
3. What is the specific role of a Conformity Assessment Body (CAB) in Malaysia's registration process?
4. Why is having a single local representative for the entire ASEAN region often not a viable strategy?
5. How will the upcoming Singapore-Malaysia regulatory reliance pilot program impact market entry strategies from 2025 onwards?
6. What are the key differences in post-market surveillance requirements between Vietnam and Thailand?
7. How do you choose the right first market in ASEAN for your specific device class?
At Pure Global, we offer end-to-end regulatory consulting solutions for MedTech and IVD companies. We combine local expertise with advanced AI and data tools to streamline your global market access, turning regulatory hurdles into strategic advantages. To learn how we can accelerate your entry into the ASEAN market, contact us at [email protected] or visit https://pureglobal.com/.