Rewellio continues to grow its markets internationally and as some of you know from previous mentions via our social media channels, we have just received our official approval for certification as a class 1 medical device by The Therapeutic Goods Administration (TGA). The TGA is the regulatory body for therapeutic goods in Australia and it is a Division of the Australian Department of Health established under the Therapeutic Goods Act 1989. As a result of this approval, patients and therapists in Australia will now have full access to rewellio, yeah!
“Each market has its own strict regulatory laws and requirements and rewellio strives to meet these every time we enter a new market. We are very glad to have accomplished yet another milestone with the approval by the TGA in Australia”
Bernhardt Kern, Rewellio’s Chief Regulatory Officer
As part of this market expansion effort, rewellio also established a new Australian entity, “Rewellio Pty Ltd”, with an office location “down under” on the east coast of Australia. A big shout out to our Chief Regulatory Officer, Bernhardt Kern, who has led this effort and made it a success today largely due to his vast experience with medical certifications over the last 14 years or so.