AI Medical Devices in Malaysia: Driving Innovation While Safeguarding Patient Safety

AI Medical Devices in Malaysia – Balancing Innovation & Safety

Futurise Sdn Bhd, in partnership with the Medical Device Authority (MDA), recently hosted RegTalk at the Siemens Healthineers Experience Center in Cyberjaya, Malaysia. The discussion focused on the integration of artificial intelligence (AI) in medical devices and the crucial balance between fostering innovation and ensuring patient safety.

The event gathered regulators, industry leaders, and policy experts to address opportunities and challenges presented by AI in healthcare. Key topics included clinical validation, ethical data use, and maintaining public trust while encouraging technological advancement.

Malaysia’s Approach to AI in Healthcare

Shafinaz Salim, Acting CEO of Futurise, emphasized Malaysia’s pivotal role in advancing digital health. She highlighted how AI technologies—from predictive diagnostics to real-time patient monitoring—offer significant benefits but also require careful oversight to protect public safety and maintain clinical integrity.

Shafinaz announced plans to collaborate with MDA to establish Malaysia’s first regulatory sandbox for medical devices. This sandbox will provide a controlled environment for innovators to test AI-driven medical technologies safely under regulatory supervision.

What is a regulatory sandbox?
It’s a platform that allows experimentation with new medical technologies without the immediate pressure of full regulatory compliance. This setup encourages rapid prototyping, real-world validation, and helps accelerate the adoption of safe, patient-focused innovations.

Regulatory Perspectives on AI Medical Devices

Aidahwaty M. Olaybal, Senior Director at MDA, stressed the importance of adaptive regulatory frameworks that keep pace with AI technology evolution. She noted that collaboration among regulators, developers, clinicians, and ethicists is essential to build trust and ensure devices perform reliably across diverse clinical settings.

Aidahwaty pointed out that regulatory sandboxes enable safe testing and iteration, supporting continuous education for all stakeholders involved. This approach helps align innovation with patient safety and ethical standards.

Panel Discussion Highlights

• Regulatory harmonisation: Aligning Malaysia’s regulations with international best practices to facilitate broader acceptance and market access.
• Ethical AI deployment: Addressing data privacy, transparency, and bias in AI algorithms.
• Accelerating adoption: Strategies that encourage responsible implementation of AI-powered medical devices in healthcare settings.

The panel, moderated by Deepak Pillai from Christopher & Lee Ong Malaysia, featured leaders from MDA, Siemens Healthcare Singapore, and Asia Group Advisors. Their insights reinforced the need for public-private collaboration to strengthen Malaysia’s digital health ecosystem.

Building an Enabling Ecosystem

Futurise highlighted that a successful AI medical device ecosystem requires active engagement from all players in the healthcare value chain, including regulators, clinicians, innovators, investors, and patients. Open dialogue, knowledge-sharing, and capacity-building are key to fostering trust and accelerating progress.

As the regulatory sandbox framework develops, the focus remains on patient-centric outcomes and safety. This initiative supports Malaysia’s goal to become a leader in digital health innovation while maintaining high standards of care and trust.

For healthcare professionals interested in understanding AI technologies and their applications further, exploring dedicated AI training courses can be valuable. Resources such as Complete AI Training offer practical programs tailored to various skill levels and job roles.

Looking Ahead

The RegTalk 2025 outcome lays the groundwork for a regulatory environment that supports innovation in a structured, risk-managed way. By embracing regulatory sandboxes, Malaysia aims to accelerate safe AI medical device adoption and contribute to the broader ASEAN healthcare landscape.

This balanced approach ensures that technological advancements translate into real-world benefits without compromising safety or public confidence.