This episode delves into the critical process for medical device manufacturers to regain control of their Singapore market access by transitioning from a distributor-held registration to an independent registrant. We explain why tying your regulatory license to a commercial partner creates business risks and outline the strategic advantages and procedural steps involved in making the switch with Singapore's Health Sciences Authority (HSA).

Key Questions:

• What is an HSA Registrant and why is it mandatory for selling medical devices in Singapore?

• Are you unknowingly locked in with your current Singaporean distributor?

• What happens to your product license if you terminate your distributor agreement?

• How does appointing an independent representative give you full control over your market access?

• What is the official process for changing your Local Authorized Representative with the HSA?

• Why can't you simply "transfer" your existing medical device registration to a new entity?

• What key document do you need to authorize a new independent registrant?

• How does this change impact your ability to work with multiple distributors?

• What are the long-term benefits of separating your regulatory and commercial partners?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.