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Unlocking Southeast Asia's MRI Market: A Pure Global Guide to Navigating Regulations in Singapore, Malaysia, and Vietnam
The market for MRI systems in ASEAN is expanding rapidly, driven by increased healthcare investment and demand for advanced diagnostics. However, medical device manufacturers often underestimate the complexities of navigating the region's fragmented regulatory landscape. While the ASEAN Medical Device Directive (AMDD) aims for harmonization, each member state presents unique challenges in device classification, registration, and post-market surveillance.
This episode delves into the practical realities of bringing an MRI system to market across Southeast Asia. We explore the specific hurdles faced, from differing national interpretations of regulations to the on-the-ground infrastructure challenges that dictate which types of devices will succeed.
A Case Study in Complexity: A leading European MedTech company planned to launch its new AI-enhanced MRI system across ASEAN, expecting a straightforward process. They were quickly stalled. Regulators in Malaysia demanded local clinical data they didn't have, Vietnam's rules for software as a medical device were unclear and required lengthy consultations, and their high-tech system was unsuitable for the infrastructure available in rural hospitals in the Philippines. This resulted in a costly, 18-month delay to their market entry.
Key takeaways from this episode:
1. How does the ASEAN Medical Device Directive (AMDD) create both opportunities and hidden obstacles for MRI manufacturers?
2. Why might a refurbished 1.5T MRI system be more successful in Indonesia than a brand new 3T system?
3. What are the critical differences in registering AI-powered imaging software in Singapore versus Vietnam?
4. How can you prepare a single technical dossier that satisfies the varying requirements of multiple ASEAN countries?
5. What are the most common post-market surveillance mistakes companies make in this region?
6. Why is understanding local infrastructure as important as understanding local regulations?
7. How do you build a multi-country registration strategy without incurring crippling costs and delays?
At Pure Global, we offer end-to-end regulatory consulting solutions for MedTech and In-Vitro Diagnostic companies. We combine local expertise in over 30 markets, including key ASEAN countries, with advanced AI and data tools to streamline your global market access. Let us help you navigate the maze of ASEAN regulations. Contact us at [email protected] or visit https://pureglobal.com/.
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By Ran ChenThe market for MRI systems in ASEAN is expanding rapidly, driven by increased healthcare investment and demand for advanced diagnostics. However, medical device manufacturers often underestimate the complexities of navigating the region's fragmented regulatory landscape. While the ASEAN Medical Device Directive (AMDD) aims for harmonization, each member state presents unique challenges in device classification, registration, and post-market surveillance.
This episode delves into the practical realities of bringing an MRI system to market across Southeast Asia. We explore the specific hurdles faced, from differing national interpretations of regulations to the on-the-ground infrastructure challenges that dictate which types of devices will succeed.
A Case Study in Complexity: A leading European MedTech company planned to launch its new AI-enhanced MRI system across ASEAN, expecting a straightforward process. They were quickly stalled. Regulators in Malaysia demanded local clinical data they didn't have, Vietnam's rules for software as a medical device were unclear and required lengthy consultations, and their high-tech system was unsuitable for the infrastructure available in rural hospitals in the Philippines. This resulted in a costly, 18-month delay to their market entry.
Key takeaways from this episode:
1. How does the ASEAN Medical Device Directive (AMDD) create both opportunities and hidden obstacles for MRI manufacturers?
2. Why might a refurbished 1.5T MRI system be more successful in Indonesia than a brand new 3T system?
3. What are the critical differences in registering AI-powered imaging software in Singapore versus Vietnam?
4. How can you prepare a single technical dossier that satisfies the varying requirements of multiple ASEAN countries?
5. What are the most common post-market surveillance mistakes companies make in this region?
6. Why is understanding local infrastructure as important as understanding local regulations?
7. How do you build a multi-country registration strategy without incurring crippling costs and delays?
At Pure Global, we offer end-to-end regulatory consulting solutions for MedTech and In-Vitro Diagnostic companies. We combine local expertise in over 30 markets, including key ASEAN countries, with advanced AI and data tools to streamline your global market access. Let us help you navigate the maze of ASEAN regulations. Contact us at [email protected] or visit https://pureglobal.com/.