ASEAN MedTech Insights

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

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

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

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,

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