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, provided regulatory strategy is addressed early.

What You Will Learn

This webinar explores how ASEAN regulatory systems work in practice, including:

• 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

Watch the On-Demand Webinar

Watch the recording at your convenience to gain practical guidance on navigating ASEAN regulatory requirements and planning a successful market-entry strategy.

Who Should Watch

This webinar is intended for:

• 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