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International Cooperation

The concerns of public safety and healthcare are normally shared by all governments. This is why the European Commission has engaged in a number of policy and regulatory dialogues with its counterparts in the key trade partners of the EU in the field of medical technology.

This bilateral cooperation is mainly carried out with the US Food and Drug Administration (FDA), Japan MHLW, Health Canada, Australia TGA, China SFDA and AQSIQ. The bilateral cooperation with Australia, Canada, Japan and the USA feeds a multilateral framework i.e. IMDRF (the International Medical Device Regulator’s Forum). The active participation of Europe in IMDRF aims at contributing to the definition of a global regulatory model for medical device and diagnostics technology and the drafting of guidance documents agreed by consensus.

A Mutual Recognition Agreementpdf(70 kB) Choose translations of the previous link  on conformity assessement is established with Australia since 1 January 1999. Medical device amendments to the EU-Australia MRA will come into effect 1 January 2013.

More detailed Information on the multilateral and bilateral policy and regulatory dialogues can be found under the following links: