Navigating the complex regulatory landscape of Southeast Asia can be challenging, especially when it comes to low-risk medical devices. While the term "exemption" suggests an easy path to market, the reality across ASEAN is far more complex. This episode demystifies the rules for Class A devices in key markets like Singapore, Malaysia, and Thailand, revealing that a true exemption is the exception, not the rule. We explore how different national authorities interpret and implement the ASEAN Medical Device Directive (AMDD). From Singapore's unique licensing requirements for "exempt" devices to Malaysia's mandatory registration for all classes, we provide the critical details you need to avoid common and costly market entry mistakes. **Real-World Challenge:** Imagine launching a new Class A diagnostic tool. You see that Singapore offers an "exemption," so you ship your product, only to have it held indefinitely at customs. The reason? While the product itself doesn't need registration, your company or your local partner was never licensed as a dealer—a crucial step for even exempt devices. This oversight not only halts your launch but also leads to unexpected costs and strains your new business relationships. **This Episode's Key Questions:** 1. Does "low-risk" truly mean "no paperwork" for MedTech devices in the ASEAN region? 2. Why is a Class A device in Singapore treated differently than the exact same device in Malaysia? 3. What is the single most common and costly mistake companies make when dealing with "exempt" devices? 4. How can a local representative be critical even if your product doesn't need full registration? 5. Are you prepared for the specific documentation needed for a simple "notification" or "listing" process? 6. Which ASEAN countries require mandatory registration for all device classes, without exception? 7. How do licensing requirements for importers and distributors affect your market access strategy? 8. What hidden compliance steps can derail your product launch in an otherwise straightforward market? At Pure Global, we specialize in transforming these regulatory complexities into clear, actionable market access strategies. Our team offers end-to-end regulatory consulting, combining deep local expertise with advanced AI tools to streamline your entry into over 30 global markets, including the entire ASEAN region. Whether you need a local representative, technical dossier preparation, or a full registration strategy, we are your trusted partner. Don't let regulatory hurdles slow your growth. Contact us at [email protected] or visit https://pureglobal.com/ to learn how we can accelerate your success.