I have past experience dealing with both the TGA and FDA for...

I have past experience dealing with both the TGA and FDA for product approval. TGA has a reputation for been one of the toughest regulatory body's in the world and as such their approval is the biggest hurdle already crossed. The 2 countries probably have different criteria and hence the TGA approval is not an automatic stamp by the FDA. However, we talking about a non invasive piece of equipment so their are not many aspects a regulatory body will have a concern with. Plus the machine does not cure anything, so they don't have to prove any therapeutic claims. Anyhow the process is fairly quick, 2 - 8 weeks depending upon workload and staff levels in the departments.