Getting a high-risk, Class III medical device to market is a major hurdle. While securing FDA approval is a huge milestone, many companies assume this translates to easy access in key ASEAN markets like Singapore. In this episode, we explore the reality of this process. We break down Singapore's Health Sciences Authority (HSA) abridged evaluation route for devices with prior FDA approval. Discover how this pathway can accelerate your market entry, but also learn about the critical nuances and local requirements that are often overlooked.

Case In Point: We examine the case of a US company with an FDA-approved cardiovascular stent. They expected a quick registration in Singapore but hit unexpected roadblocks. Learn how they navigated the requirement for a local registrant and addressed specific HSA queries, ultimately cutting their registration time in half compared to a full evaluation.

In This Episode, You'll Learn:

- Why is Singapore a top-tier entry point for MedTech in ASEAN?

- How does the HSA view prior approval from the US FDA?

- What exactly is an "abridged evaluation," and how does it differ from a full review for a Class III device?

- Is FDA approval a guarantee for faster registration in Singapore?

- What are the common pitfalls companies face even with a strong US dossier?

- Why is a local Singapore Registrant essential for your application?

- What kind of questions can you expect from the HSA during the review?

Navigating global regulations requires local expertise and a strategic approach. At Pure Global, we offer end-to-end regulatory consulting solutions for MedTech and IVD companies, using local experts and advanced AI to streamline your global market access. Don't let regulatory hurdles slow your growth. Contact us at [email protected] or visit https://pureglobal.com/ to learn how we can help.