In this episode of ASEAN MedTech Insights, we demystify the regulatory landscape for AI-powered medical devices in Singapore. As a leading MedTech hub in ASEAN, Singapore's Health Sciences Authority (HSA) has established a robust framework that, while not specific to AI, presents unique challenges for innovators. We explore how the HSA applies its risk-based classification to AI devices and what this means for your market entry strategy.

This session breaks down the critical "life cycle approach" that the HSA requires, moving beyond pre-market approval to address the dynamic nature of AI algorithms. We discuss the essential guidelines and international standards that shape Singapore's regulatory environment, providing a clear roadmap for companies looking to launch their cutting-edge AI technologies in this key market.

**Case Study Highlight**

Consider this challenge: You've developed a groundbreaking AI algorithm that detects diabetic retinopathy, but you plan to continuously update and improve it with new data. How do you manage these changes without violating HSA regulations?. This episode uses this exact case to illustrate the pain point of post-market compliance for learning algorithms, explaining HSA's requirements for an "Algorithm Change Protocol" and the critical difference between minor and significant changes.

**What You'll Learn**

- How does Singapore's HSA classify the risk of AI-powered medical devices?

- Is there a separate, unique regulatory pathway for AI in Singapore?

- What is the single most important guidance document you need to master for your software device submission?

- How do global standards from the IMDRF influence your HSA registration process?

- What are HSA’s strict expectations for managing AI algorithm changes and updates after your product is on the market?

- Why is a "total product lifecycle approach" so critical for AI device compliance in Singapore?

- What level of clinical evidence does a high-risk diagnostic AI, like one for oncology, need to provide?

- How significant is cybersecurity in your HSA submission dossier?

Ready to bring your MedTech innovation to Singapore and other key ASEAN markets?. Navigating the complex regulatory requirements for AI and software medical devices is our expertise. Pure Global offers end-to-end regulatory consulting solutions, combining local expertise with advanced AI tools to streamline your global market access. We act as your local representative, develop efficient regulatory strategies, and manage your technical submissions to ensure a smooth path to approval.

Contact our experts today to build your market entry strategy. Email us at [email protected] or visit https://pureglobal.com/.