An US-based innovator in women’s reproductive health and sexual wellness products wanted to enter the Australian market. The client was looking for a Regulatory partner to outsource end-to-end activities in ARTG listing and to act as an Australian Sponsor on their behalf. There were multiple devices in scope along with their accessories and the client was not sure on grouping the medical devices into one application. In addition, identifying the right GMDN codes for the devices and accessories were critical, few devices were CE self-certified and few were CE marked by the Notified Bodies and the labels had to be revised for inclusion of sponsor details for importing and marketing the devices in Australia.
Amidst all the challenges, how did Freyr evaluate all the device variants and achieve the hassle-free Australian market entry? Discover with this proven case.