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TGA medical devices listing on the Australian Register of Therapeutic Goods (ARTG)
TCA can be your Australian agent and register your medical devices with the TGA. For this, your devices will require full European certification under the European Medical Directive.
What you need to send to TCA:
- EC certificate issued by European notified Body (quality system for the manufacturer certified as a medical devices manufacturer). An ISO 13485 certificate is not considered sufficient as it does not describe the Conformity Assessment Procedure (relevant Annex in the MDD).
- Copy of the device CE certificate from European Notified Body (as applicable)
- Sample of device including rating labels and instruction manual
- Manufacturer’s declaration to the European MDD including device classification and GMDN
- Manufacturer’s declaration to the Australian Therapeutic Goods Amendment (Medical Devices) Act 2002
- Australian sponsor details
What we offer:
- Review all documents and prepare the technical folder for the sponsor
- Prepare the on-line SIME application and discuss all technical matters with the TGA
- Register and act as a compliance agent for the Australian sponsor (optional)
- Pay TGA fees and arrange for the inclusion of the device on the ARTG
- Act as a first point of contact for TGA technical inquires related to the device.
If you require more information about TGA Agency services please contact Gunther Theisz.
Testing & Certification Australia
Product Compliance |
14 Nelson Street
Chatswood NSW 2067
Australia
Ph: +612 9410 5111
Fax: +612 9415 1567 |
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