Episode Details

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 importer's and a wholesaler's license under HSA? - What Quality Management System (QMS) certifications does the HSA accept? - Is an ISO 13485 certificate always sufficient for a Singapore dealer license application? - What is GDPMDS and why is it important for Singapore market access? - Do manufacturers in Singapore need a separate license to sell their own products? - Are there any license exemptions for low-risk medical devices? Navigating complex regulations like Singapore's dealer licensing is where Pure Global excels. We offer end-to-end regulatory consulting for MedTech and IVD companies, acting as your local representative and using advanced AI to streamline dossier submission. Our experts ensure your Quality Management System meets HSA standards, paving a smoother path to market entry. Whether you're a startup or a multinational, we can help you access over 30 global markets faster. Contact Pure Global at info@pureglobal.com, visit us at https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.