Tag: overseas manufacturer

REGULATORY ALERT – AUSTRALIA How your Singapore HSA Approval Can Fast-Track TGA Registration in Australia If your medical device is registered with Singapore’s Health Sciences Authority, you already have most of what you need for Australian ARTG inclusion. Singapore-based manufacturers and Asia-Pacific distributors If your device is registered with Singapore’s Health Sciences Authority (HSA), you’re…

REGULATORY ALERT – AUSTRALIA Do I Need an Australian Sponsor for My Medical Device? If you’re an overseas medical device manufacturer looking to sell in Australia, you almost certainly need an Australian Sponsor. Here’s exactly when it’s required, what the Sponsor is responsible for, and what happens if you try to supply without one. Who…