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

Learn how to navigate ASEAN regulatory systems with confidence in this deep-dive session covering medical device and SaMD classification under the ASEAN Medical Device Directive (AMDD), along with key differences in registration pathways across Singapore, Malaysia, Vietnam, Indonesia, and the Philippines. The session examines approval timelines, license validity, and registration costs, while highlighting product grouping strategies and common submission pitfalls that can increase regulatory workload and delay approvals. For more information, explore our medical device registration services across Southeast Asia: https://cisema.com/markets/our-servic... Webinar Speakers Shouzheng Tan – VP Southeast Asia (  / tan-shouzheng-1b359a161  ) Victoria Caldy – Business Development & Marketing Director (  / victoriacaldy  ) Connect with Us Website: https://cisema.com?utm_source=youtube... LinkedIn:   / cisema   X: https://x.com/CisemaHK/ ✉️Newsletter: https://webforms.pipedrive.com/f/1EjJ... Key Chapters 00:00 – Introduction 01:04 – Southeast Asia Medical Device Market Overview 04:55 – Medical Device Classification & SaMD Regulatory Framework 16:00 – Regulatory Timelines & ASEAN Reliance Pathways 27:30 – SaMD Market Considerations & Emergency Pathways 33:09 – Medical Device Licensing Models & Authorised Representation 39:02 – Q&A Session About Cisema Founded in 2002, Cisema is a leading provider of regulatory affairs, quality compliance, clinical research, and product testing and safety certification services across China and the broader APAC region, supporting start-ups to multinationals with product approvals of all classes and specifications. With more than ten global offices and service centers throughout China, South Korea, and Southeast Asia, we enable compliance for regulated products across sectors including, but not limited to, medical devices, IVDs, pharmaceuticals, biotech, cosmetics, health supplements, and industrial and consumer goods.