MRA certificates of conformity issued by the TGA
Australia has signed a Mutual Recognition Agreement (MRA) with the European Union (EU) and the European Free Trade Association (EFTA), covering several industry sectors including the medical devices sector. For more information on MRAs please see Section 9. International agreements.
Under the MRAs, the Australian Government has designated the TGA as the Conformity Assessment Body responsible for assessing devices manufactured in Australia to the requirements of the Medical Devices Directive and the Active Implantable Medical Devices Directive. Australian manufacturers who receive a MRA certificate from the TGA are then able to affix the CE Mark and supply in Europe.
However, the TGA can only issue EC certificates to manufacturers established within Australia or New Zealand. For a manufacturer to be eligible for an EC certificate under the Australia-EU/EFTA MRAs the manufacturer must demonstrate that the device is fully (or mostly) manufactured within Australia and/or New Zealand. Some kinds of devices are also excluded from the agreement, or are subject to confidence building activities.
EC MRA certificates are not issued by the TGA in accordance with the Therapeutic Goods Act 1989, but are covered by a contractual arrangement between the manufacturer and the Commonwealth of Australia (which is represented by the TGA). The TGA issues EC certificates under the MRAs as an extension to an application for an Australian TGA Conformity Assessment Certificate.
An application for an EC certificate is submitted with an application for a TGA Conformity Assessment Certificate. The TGA conducts both assessments at the same time as the requirements are similar but there are some differences. If the applicant is issued with a TGA Conformity Assessment Certificate and is found to also satisfy the additional EU/EFTA requirements, the TGA will issue an EC certificate. Additional fees are payable for this assessment. For more information please see Section 2. Fees and charges for medical devices.
If a manufacturer intends to obtain EC certification from the TGA, it is important that they establish an European Representative in the EU/EFTA and seek advice on the particular requirements applying to the EU/EFTA area/state where they intend commercialising the medical device.
Manufacturers should obtain a copy of the relevant EU Directives before applying to the TGA for EC certification. More information on the European requirements can be obtained from <http://www.newapproach.org/Directives/DirectiveList.asp>.