Australia - European Community mutual recognition agreement (EC-MRA)
Mutual recognition agreement
The Mutual Recognition Agreement (MRA) on standards and conformity assessment between Australia and the European Community (EC) was signed in Canberra on 24 June 1998 and came into effect on 1 January 1999. The MRA covers eight industry sectors of which the Therapeutic Goods Administration (TGA) has responsibility for two; medicinal products GMP inspection and batch certification, and medical devices conformity assessment.
Medical devices
The EC-MRA applies to medical devices manufactured in the European Community, Australia and New Zealand. The MRA recognises the competence of designated conformity assessment bodies (CABs) in the EC to undertake conformity assessment of medical devices to Australian regulatory requirements. Conversely, the EC recognises the competence of the TGA to undertake assessment of medical devices for compliance with the requirements for certification ('CE Marking') for entry onto the EC market.
Overall, for Australian manufacturers, it means products for export to the European Community can be assessed to European requirements more cost effectively and more quickly than at present. Devices imported under the MRA from the European Community can be placed on the Australian market more quickly than present.
Devices incorporating animal derived tissues, radioactive materials, in vitro diagnostics and devices manufactured in other countries, such as the United States, (even those devices that have CE marking) are excluded.
For registrable devices, the MRA includes an 18-month transition period to allow each party to gain confidence in the other's procedures and processes for the premarket assessment of registrable devices.
Conformity assessment
- How to apply for a conformity assessment certificate and/or an EC certificate of conformity under the EU-Australia MRA
<http://www.tga.gov.au/docs/html/devguid26.htm> - Conformity assessment bodies (CABs) approved to undertake assessments to Australian requirements (pdf,27kb)
Exporting from Australia
Medical devices directive checklist (pdf,61kb)
Importing to Australia
Application Supplement (for use in Registration/Listing applications under MRA provisions)
The Therapeutic Devices Application Form and Supplement are no longer available on this website. Sponsors are now required to use the Device Electronic Application Lodgement (DEAL) system <http://www.tga.gov.au/online/deal.htm> to apply for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG). DEAL may be accessed at http://www.tgasime.health.gov.au. For further information on the DEAL system, please phone 1800 010 624 or email tga.sime@tga.gov.au.
Medicinal products GMP
The MRA allows EU member countries to recognise certificates of conformity issued by Australia using Australian conformity assessment or inspection rules and regulations, and vice versa. That is, the MRA provides for conformity assessment to be carried out in the country of manufacture.
The MRA became operative on 1 January 1999 and covers various other industry sectors including medical devices, machinery, pressure equipment, low voltage equipment, telecommunication terminal equipment, electromagnetic compatibility and automotive parts.