Swissmedic swissdamed Importer Linking: April 1, 2027 Deadline for Medical Device Importers

Swissmedic has activated the importer linking function in the swissdamed database as of October 1, 2026. This creates a new mandatory step for Swiss importers, who now have until April 1, 2027, to electronically link their actor registration (CHRN) to the devices they place on the market. This episode breaks down the new obligation, explains its dependency on prior device registration by manufacturers and Swiss Authorized Representatives (CH-REPs), and outlines practical steps for all economic operators to ensure compliance before the deadline. Key Questions: - What is the new importer linking function in Swissmedic's swissdamed database? - When did this new requirement become active? - What is the final deadline for Swiss importers to link devices? - Why is collaboration with manufacturers and CH-REPs essential for compliance? - What happens if a device is not registered by the manufacturer in swissdamed? - How does this linking process affect the responsibilities of a Swiss importer? - What practical steps should importers take now to prepare for the April 1, 2027 deadline? - How does the UDI-DI play a role in this new process? - What are the consequences of failing to link devices by the deadline? Sources: - https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance/importers.html - https://www.medenvoy.com/resources/news/swissmedic-activates-swissdamed-importer-linking - https://www.pure-global.com/insights/swissdamed-importer-links-by-1-april-2027/ - https://www.simone-ronco.com/en/blog/swissdamed-importers-linking-devices - https://www.europe-it.com/blog/swissdamed-linking-of-udis/ How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you access global markets faster. Our experts offer services like regulatory strategy, technical dossier preparation, and local representation in over 30 countries, including Switzerland. We can guide you through Swissmedic requirements, manage your swissdamed registrations, and ensure your quality systems are compliant. By combining local expertise with advanced AI, we streamline the entire process, from initial registration to post-market surveillance. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more. Explore our free AI tools and regulatory database at https://pureglobal.ai.