Pure Global's ASEAN MedTech Insights: Navigating Singapore's Class A Maze and the Hidden Dealer License Rule

This episode of ASEAN MedTech Insights tackles a critical compliance hurdle in Singapore that catches many MedTech companies by surprise. We explore why the "registration-exempt" status for Class A medical devices is not a free pass to the market and detail the mandatory licensing requirements that are often overlooked. Many international manufacturers assume their low-risk Class A devices can be sold in Singapore without regulatory steps, leading to costly mistakes. We share a real-world case where a company's product launch was completely stalled at customs because their local distributor lacked the required license, a detail that was missed in their market entry strategy. This scenario highlights the hidden complexities and the importance of deep local regulatory knowledge. Key Takeaways: * What does "registration-exempt" for Class A devices in Singapore truly mean for a manufacturer? * Why is a dealer's license mandatory even when the product itself doesn't need to be registered? * What are the real-world consequences of ignoring this critical licensing requirement? * How does the Health Sciences Authority (HSA) maintain supply chain oversight for low-risk devices? * What is GDPMDS and why is it an essential certification for your Singaporean partners? * Are you certain your local distributor is fully compliant to import and sell your Class A device? * How can you avoid unexpected customs delays and regulatory penalties in Singapore? At Pure Global, we provide end-to-end regulatory consulting to help MedTech innovators navigate complex markets like Singapore and the broader ASEAN region. Our blend of local expertise and advanced data tools streamlines market access and ensures you are compliant every step of the way. Don't let regulatory surprises derail your expansion. Contact us at [email protected] or visit https://pureglobal.com/ to secure your path to market.

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