Latest / Medical Device Global Market Access
Singapore MedTech Market: A Guide to HSA's Importer, Wholesaler & Manufacturer Licenses
This episode provides a detailed guide to the three types of medical device dealer licenses required by Singapore's Health Sciences Authority (HSA): manufacturer, importer, and wholesaler. We clarify the specific activities each license permits and highlight the critical, non-negotiable requirement for a compliant Quality Management System (QMS), referencing key standards like GDPMDS and ISO 13485. - What are the three types of dealer licenses for medical devices in Singapore? - If I import a device, do I automatically have the right to sell it wholesale? - What is the difference between an…
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