A France-based digital dentistry company approached Freyr to provide end-to-end Regulatory services and to act as an authorized representative to register their device in Australia and New Zealand. Though the client had a plan for the Australian market-entry, they were unaware of the Australian regulations, process and procedures for inclusion of the device in the ARTG database and the roles and responsibilities of various stakeholders. In addition, it was challenging to get a precise understanding of the technology used to support the device registration in the target countries and responding to the TGA queries.
How did Freyr overcome the challenges and ensured a hassle-free device registration process? Discover with this proven case. Download.