Free Webinar: Southeast Asia Market Entry: Regulatory Strategy for Medical Devices & SaMD

Southeast Asia is one of the fastest-growing regions for medical devices and software — but entering these markets requires careful regulatory planning across multiple jurisdictions.

This webinar provides a structured, practical overview of how to approach ASEAN regulatory systems, helping you plan market entry with greater clarity and control.

Why Southeast Asia — and Why Now

• 80% to 99% of medical devices are imported across key markets
• Demand is increasing due to aging populations, chronic disease, and hospital modernization
• Regional trade agreements are reducing barriers and simplifying market access
• Strong growth in diagnostics, imaging, and digital health technologies

For manufacturers with established products, Southeast Asia offers a realistic and scalable expansion opportunity — if regulatory strategy is addressed early.

What You Will Learn

This session focuses on how ASEAN regulatory systems work in practice.

• How medical devices and SaMD are classified under the ASEAN Medical Device Directive (AMDD)
• Key differences in registration pathways across Singapore, Malaysia, Vietnam, Indonesia, and the Philippines
• How reliance and abridged pathways are applied within ASEAN
• Typical approval timelines, license validity, and cost considerations
• How product grouping strategies can reduce registration workload
• Common regulatory and submission pitfalls that delay approvals

Why Attend

This webinar is designed to help you make better-informed market-entry decisions.

You will leave with:

• A clearer basis for prioritizing and sequencing ASEAN markets
• Practical insight into how to reduce time to market through structured planning
• Clarity on how existing approvals can support regional expansion strategies
• A defined view of your next regulatory step for Southeast Asia entry

Who Should Attend

• Regulatory affairs leaders managing global submissions
• Executive teams evaluating Southeast Asia expansion
• Quality and compliance professionals supporting market entry
• Commercial and market-entry strategy teams
• Medical device and SaMD manufacturers preparing for ASEAN registration