If you plan to sell medical devices in Australia, obtaining approval from the Therapeutic Goods Administration (TGA) is a crucial step. However, if your product already has certification from a comparable overseas regulator, you can leverage this to streamline the approval process in Australia. This approach can save you significant time, effort, and money.
The TGA recognises international assessments and approvals from several reputable regulatory bodies, including:
- European Union Notified Bodies
- U.S. Food and Drug Administration (FDA)
- Health Canada
- Japan’s Ministry of Health, Labour and Welfare
- Singapore’s Health Sciences Authority (HSA)
- Medical Device Single Audit Program (MDSAP) Auditing Organisations.
By using your existing overseas certification, you can potentially reduce the extent of the TGA’s conformity assessment. This means fewer hurdles to clear, accelerating your product’s entry into the Australian market. To make the process smoother, we’ve created a checklist that outlines everything you need to know about using your overseas certification effectively. Just fill out the form below, and we’ll send you a link to download the checklist directly.
One essential step is employing a sponsor to submit your TGA application. If you need assistance, Johner Institute New Zealand, in partnership with Svante Medical, offers expert sponsorship services for both the Australian and New Zealand markets. Contact us today to learn more about our sponsorship services and how we can assist you in achieving regulatory approval.
