TGA Annual Invoicing Time – Avoid ARTG Cancellations

If you are a medical device sponsor, you would have received or you are about to receive the TGA annual charge invoice. It is important to ensure all your details are up to date with the TGA and that the payment of the invoice is done no later than September 15^th to avoid cancellations of your ARTG Certificate.

If you qualified in the past for the Low Value Turnover (LVT) scheme, from July 1^st 2015 the scheme was replaced by the Annual Charge Exemption (ACE) scheme. The TGA pre-qualified certain entries that received LVT exemptions in the 2013-14 and/or 2014-15 financial years for the ACE scheme. You should have received a TGA letter confirming the pre-qualified entries. If you haven’t receive any notification from the TGA yet ensure details are accurate through your on-line TGA Business Service Portal.

KD&A is medical device consultancy firm made of TGA Agents that specialise in medical devices and IVDs. For any regulatory enquiries regarding medical devices and IVDs contact KD&A on +61 4 11 101 392 or email us at kdent@kdas.com.au.