Latest / Medical Device Global Market Access
Singapore MedTech Compliance: Navigating HSA Registrant & Representative Roles
This episode details the mandatory requirement for foreign medical device manufacturers to appoint a Singapore Registrant. We explain the role and responsibilities of this local authorized representative as required by the Health Sciences Authority (HSA), the strategic implications of choosing a representative, and how it impacts market access for Class B, C, and D devices. - What is a Singapore Registrant and why is it mandatory for foreign manufacturers? - Who is eligible to act as a local authorized representative in Singapore? - What are the key legal responsibilities of the company…
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