On 28 August 2025, Futurise Sdn Bhd, a wholly-owned subsidiary of Cyberview Sdn Bhd under the Ministry of Finance, in collaboration with the Medical Device Authority (MDA), hosted RegTalk 2025: AI Medical Devices in Malaysia – Balancing Innovation and Safety at the Siemens Healthineers Experience Center, Kuala Lumpur.
The session brought together regulators, industry leaders, policy experts, and healthcare professionals to explore the transformative role of AI in the medical device sector — while addressing the equally important aspects of safety, clinical validation, and ethical data governance.
Scope
The event served as a platform to discuss Malaysia’s regulatory direction on AI-driven medical devices, focusing on innovation, validation, ethics, and safety.
Key Highlights
Panel Moderation and Speakers
- he panel was moderated by Deepak Pillai (Partner, Christopher & Lee Ong).
- Featured insights from:
- Idamazura Idris @ Harun, Senior Director, Policy & Strategic Planning Division, MDA
- Dr. Ylu-Cho Chung, Head of Research Collaboration, Siemens Healthcare
- Ella Al-Hakim, Associate, Asia Group Advisors
Announcements and Statements
- Shafinaz Salim (Acting CEO, Futurise):
Announced plans to establish Malaysia’s first regulatory sandbox for AI-driven medical devices, in partnership with MDA — a platform designed to accelerate responsible innovation under regulatory oversight. - Aidahwaty M. Olaybal (Senior Director, Medical Device Authority, MDA):
Emphasized adaptive regulation, real-world validation, and stronger collaboration between regulators, clinicians, developers, and ethicists to ensure trust and performance.
Key Takeaways
- Regulatory sandboxes will be vital to safely test and scale AI innovations.
- Public-private partnerships are key to enabling trust and progress.
- Malaysia is poised to position itself as a regional leader in digital health, shaping ASEAN’s tech-enabled healthcare future.
Implications for Clients
Clients interested in registering AI medical devices in Malaysia should take note of the updates and the upcoming regulatory sandbox, which will allow safe trials of AI-driven medical technologies within a controlled environment under MDA supervision.
Read the Announcement
You can access the official text of the announcement here: Futurise Lead RegTalk 2025: AI Medical Devices in Malaysia – Balancing Innovation and Safety
Effective Date
28 August 2025
Next Steps
Should you have any inquiries regarding the announcement, please don’t hesitate to reach out to us. You can contact our team at sales@andamanmed.com or click the button below for more details.
